药品批发企业GSP认证检查评定标准(试行)

药品批发企业GSP认证检查评定标准(试行) 药品批发企业GSP认证检查评定标准,试行, (国家药品监督管理局制定) 1、 为统一标准，规范药品GSP认证检查，确保认证工作质量，根据《药品经营质量管理规范》(2000.7.1)及《药 品经营质量管理规范实施细则》，制定药品批发企业认证检查评定标准。 2、 药品批发企业GSP认证检查项目共132项，其中关健项目(条款前加“*”)37项，一般项目95项。 3、 现场检查时，应对所列项目及其涵盖内容进行全面检查，并逐项作出肯定、或者否定的评定。凡属不完整、不 齐全的项目，称为缺陷项目;关健项目不合格为严重缺陷;一般项目不合格为一般缺陷。 4、 药品批发企业分支机构抽查比例30%;一个分支机构不合格，视为一个严重缺陷。 5、 结果评定: 项 目 结 果 严重缺陷 一般缺陷 0 ?10% 通过GSP认证 0 10-30% 限期3个月内整改 后追踪检查 ?2 ?10% ?2 >10% 不能通过GSP认证 >2 0 ?30% practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 安徽省药品批发企业GSP认证现场检查操作方法,试行, (安徽省药品监督管理局制定) 企业陪 编号 条 款 检查内容与方法 检查结果记录 备 注 同人员 签字 (*04企业应按照依查《药品经营许可证》、《营许可证: 有?，无法批准的经营业执照》。如有分支机构，提供?。 01) 方式和经营范分支机构《药品经营许可证》和营业执照: 有?，无围，从事药品《营业执照》。 ?。 经营活动。 核实企业实际经营活动(如是否超范围经营: 是?，否 查发票、记录、在库药品、售后?; 服务等)与证照核准的经营方式如是，超出的范围有: 和经营范围是否相符。 中药材?、中药饮片?、中成药 本条应在检查结束后判定。 ?、化学原料药?、化学药制剂 ?、抗生素?、生化药品?、生 物制品?、诊断药品?、特殊管 理药品?。 nd IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and anti2 企业应建立以(0501 主要负责人为) 1、 查设置质量领导组织的文质量领导组织: 有?，首，包括进货、 件; 无?; 销售、储运等 2、 查质量领导组织的人员构人员组成是否符合规定:是?，业务部门负责 成; 否?。 人和企业质量 3、查文件或制度中是否明确质管理机构负责 量领导组织的职责; 人在内的质量 4、询问1-2名质量领导组织成领导组织。 员，是否清楚领导组织的职 (0502企业质量领导 责。 职责是否明确: 是?，否组织的主要职) ?; 责是:建立企 成员回答出几项职责: 项。 业的质量体 系，实施企业 质量方针，并 保证企业质量 管理工作人员 行使职权。 (*06企业应设置专1、查机构设置文件; 质量管理机构: 有门的质量管理2、机构和组织应有负责人; ?，无?; 01) 机构，机构下3、 询问机构负责人，是否清楚质量管理组: 有设质量管理质量管理机构职责。与1202?，无?; 组、质量验收条结合起来查。 质量验收组: 有组。 ?，无?; practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 3 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业质量管理1、查质量否决权制度，是否明(060 制度中是否明确具有质量裁决机构应行使质确质量管理机构具有质量裁2) 权: 量管理职能，决权。 是?，否?。 在企业内部对2、查在实际经营活动中(如药 实际经营活动中是否行使了质量药品质量具有品购进、验收、不合格药品的 裁决权: 裁决权。 确认、销后退回药品验收不合 是?，否?; 格的处理等)，质量管理部门 如否，有几个品种未行使质量裁是否行使裁决权。 决权: 个。 本条应在检查结束后判定。 (060企业质量管理1、查质量管理机构职责，是否 本条职责是否明确: 是机构应负责起明确了本条职责; 3) ?，否?; 草企业药品质2、查质量 管理制度 档案管理制度下载食品安全管理制度下载三类维修管理制度下载财务管理制度免费下载安全设施管理制度下载 起草、批准、 是否指导、监督制度的执行:是量管理制度，发文的基础资料。 ?，否?; 并指导、督促 本条与0802条结合起来查。 有几项制度不是质量管理机构起制度的执行。 草: 项。 (060企业质量管理1、 查首营企业、首营品种管理制度中是否明确首营企业、首营机构应负责首制度; 品种需经质量管理机构审核: 4) 营企业和首营2、 询问质量管理机构人员1-2是?，否?; 品种的质量审名，是否清楚首营企业、首质量管理人员是否清楚审核内核。 营品种审核内容。 容: 本条与2901、3001条结合起 是?，否?。 来查。 -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA124 企业质量管理1、查质量管理机构职责，是否批件，检验报告。(060 机构应负责建明确了本条职责; 该品种相关质量5) 本条职责是否明确: 立企业所经营2、查药品质量档案，包括: 信息，并注意更新 是?，否?。 药品并包括质(1)是否建立了质量档案; 是否建立了质量档案: 量标准等内容(2)建档品种范围(应含首营 是?，否?。 的质量档案。 品种、新品种、主营品种、质量 档案内容是否完整: 不稳定品种、发生过质量问 题 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 的 是?，否?; 品种等); 如否，缺项有: (3)档案内容:药品质量档案 药品质量档案表?、质量标准?、表及该品种包括质量标准、合法 合法性证明文件?、质量状态记性证明文件、质量状态记录等内 录?。 容。(药典已收载的品种，可不 收集质量标准，但企业须有药典 有效版本) (*06企业质量管理1、 查质量事故、质量查询和质本条职责是否明确: 是机构应负责药量投诉的管理制度及质量管?，否?。 06) 品质量的查询理机构职责; 是否对药品质量查询、事故、投和药品质量事2、 查质量管理机构在实际经营诉进行调查处理及报告: 故或质量投诉活动中是否履行了职责。 是的调查、处理本条可与4001、5601条结合?，否?; 及报告。 起来查。 如否，发现几起: 起。 (060企业质量管理1、 查药品验收管理制度及质量本条职责是否明确: 机构应负责药管理机构职责; 7) 是?，否?; 品的验收。 2、 询问验收组人员1-2名，是 验收人员是否清楚验收内容及抽否清楚药品验收管理制度内 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 5 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 容及抽样规则。 样规则: 本条可与3501条结合起来 是?，否?。 查。 (060企业质量管理1、查质量管理机构职责，是否 机构应负责指明确了本条职责; 8) 本条职责是否明确: 导和监督药品2、询问保管、养护、运输人员， 是保管、养护和查有关资料、记录及现场等，?，否?; 运输中的质量判定质管机构在实际经营活 是否进行了有效地指导: 工作。 动中是否对保管、养护及运输 是中的质量工作进行了有效地 ?，否?。 指导。 本条应在检查结束后判定。 (060企业质量管理1、 查不合格药品管理制度及质 本条职责是否明确: 是机构应负责质量管理机构职责; 9) ?，否?。 量不合格药品2、 查在实际经营活动中质量管 是否对不合格药品进行审核及处的审核，对不理机构对不合格药品的审核、 理过程实施监督: 合格药品的处处理是否履行了职责。 是?，否?; 理过程实施监本条可与4004条结合起来 如否，发现几起: 起。 督。 查。 -3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C6 企业质量管理1、 查质量信息管理制度及质量本条职责是否明确: 药品验收、养护检(061 机构应负责收管理机构职责; 是?，否?; 查、用户访问、不0) 集和分析药品2、 查质量管理机构质量信息收是否对质量信息进行了收集: 良反应的质量问 质量信息。 集和分析资料(包括企业内外是?，否?; 题 部质量信息)。 是否对质量信息进行了分析: 是?，否?。 (061企业质量管理1、 查质量方面的教育、培训制法规、文件、对本 本条职责是否明确: 机构应协助开度及质量管理机构职责;; 企业情况分析 1) 是?，否?; 展对企业职工2、 查培训 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 、记录等; 是否协助开展质量管理方面的教药品质量管理3、 询问质量管理机构负责人如 育或培训: 方面的教育或何协助开展培训工作。 培训。 本条应与1701、1702条结合 是?，否?。 起来查。 (*070企业应设置与1、 查设置组织机构的文件; 药品养护组(员): 有经营规模相适2、 查组织设置是否与企业经营1) ?，无?; 应的药品验规模相适应; 是否在业务上接受质量管理机构收、养护等组3、 询问养护组(员)在业务上 监督指导: 织。企业药品是否接受质 养护组或 是?，否?。 养护员在业务量管理机构监督指导; 上应接受质量4、查养护员是否有效地开展了 管理机构的监养护工作。 督指导。 本条可与4202、4203、4204、 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 7 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 大中型企业应4205、4206、4207、4208、4209企业规模(上一年销售额): (0702 设立药品养护条结合起来查。 5000万元以上?，5000) 组，小型企业万元以下?; 应设立药品养组织设置: 养护组?，养 护组或药品养护员?。 护员。 A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-8 企业制定的制(*08 度应包括:质01) 查企业制定的质量管理制度量方针和目标 (制度应与实际经营需要相符管理;质量体是否制定了质量管理制度: 合)和询问有关人员。 系的审核;质 是1、制度是否完备; 量责任;质量?，否?; 2、制度内容是否完整; 否决的规定;缺少几个方面制度: 个; 3、制度是否符合现行的法律、质量信息管制度是否经企业主要负责人批法规规定; 理; 准、发布: 4、制度是否经企业主要负责人首营企业和首 是批准、发布; 营品种的审?，否?; 5、根据现场检查情况，核实企核;质量验收有关人员是否熟悉制度内容: 业制度与实际工作是否相符的管理;仓储 是合; 保管、养护和?，否?; 6、询问有关岗位人员3-5名(或出库复 请有关人员进行实际操作)，核的管理;有 看是否熟悉涉及本岗位工作关记录和凭证 要求的制度内容并按制度要的管理;特殊 求进行实际操作。 药品的管理; 本条应与有关条款结合起来有效期药品、 查，在检查结束后判定制度是否不合格药品和 符合要求。 退货药品的管理;质量事故、质量查询和质量投诉的管理;药品不良 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 9 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific反应报告的规定;卫生和人员健康状况的 企业应定期检1、 查制度考核计划(一般由质(*08 查和考核质量量管理部门牵头制定并组织02) 是否制定了考核计划: 是管理制度执行实施，每半年至少考核一 ?，否?; 情况，并有记次); 是否有考核记录: 是录。2、 查制度考核记录(包括考核 ?，否?。 部门、考核日期、考核人员、考核的制度名称、考核的内容、存在问题及改进措施、措施跟踪、考核工作总结、考核奖惩情况等)。 (0901企业应定期对1、 查评审计划(应在质量领导 是否制定了评审计划: 是《药品质量管小组的组织下，每年至少进行) ?，否?; 理规范》实施一次); 有无评审记录: 有情况进行内部2、 查评审记录(应将管理职责、 ?，无?; 评审。 人员与培训、设施与设备、进 有无评审报告: 有货、验收、储存与养护、出库 ?，无?; 与运输、销售与售后服务等 针对评审中存在的问题，有无纠132项基本内容作为评审对 正措施: 象，对照企业管理工作的实际 有情况，逐项进行全面评审); ?，无?; 3、 查评审报告; 4、 查纠正措施。 -3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C10 1、 查花名册、档案，检查企业(1001企业主要负责 技术职称: 人应具有专业负责人是否具有专业技术职) 初级?，中级?，高级技术职称，熟称。 ?，无?。 悉国家有关药2、询问企业负责人，了解他对 询问负责人 条，能回答 法律、法规和所经营的药品知品管理的法 条。 律、法规、规识的熟悉程度; 章和所经营药品的知识。 (*11企业质量管理 工作的负责01) 查相关文件、花名册、档案，技术职称: 人，大中型企 检查职称是否符合要求(执业药 初级(药师、助理业应具有主管 师相当于中级职称，从业药师相工程师)? 药师(含主管 当于初级职称); 中级(主管药师、中药师)或药 工程师)? 学相关专业 高级(副主任药师以上、高级(指医学、生 工程师)? 物、化学等专 业,下同)工程 其它 ? 师(含)以上 的技术职称; 小型企业应具有药师(含药师、中药师)或相关专业助理工程师(含) practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 11 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 以上的技术职 称。 企业质量管理技术职称: 任命文件、花名(*12 机构的负责人 初级(药师、助理册、员工 01) 检查方法同1101项。 应是执业药师工程师)? 或符合1101项 中级(主管药师、的相应条件。 工程师)? 高级(副主任药师以上、高级 工程师)? 其它 ? (1202企业质量管理 询问质量管理机构负责人，了 机构的负责人解他对法律、法规和专业知识的是否在岗并主持日常工作: ) 应能坚持原熟悉程度及实践经验;检查相关 是则、有实践经记录，判定是否在岗并主持日常?，否?; 验，可独立解工作。 询问负责人 条，能准确回答 决经营过程中 本条在检查结束后判定。 条。 的质量问题。 3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-12 (1401企业从事质量 职称或学历是否符合规定: 管理工作的人) 根据相关文件、花名册、档 是员，应具有药 案，查专职质量管理人员: ?，否?; 师(含药师、 1、职称或学历是否符合要求; 如否，有几人: 人。 中药师)以上 2、是否有省局核发的合格证书。 技术职称或者 3、专职人员是否在职在岗(在具有中专(含) 企业内外部均不得兼职)。 以上药学或相 1401、1402、1403条与1504关专业的学 条结合起来查。 历。 质量管理工作专职人员是 (1402企业从事质量企业培训，考试合 指在1504条规定的比例内，从是否经专业培训并取得省局岗位管理工作的人格 ) 事质量管理工作的人员。 合格证: 员应经专业培 是训和省级药品 ?，否?; 监督管理部门 如否，有几人: 人。 考试合格，取 得岗位合格证 后方可上岗。 (*140企业从事质量是否在职、在岗: 管理工作的人 是3) 员应在职在?，否?; 岗，不得为兼如否，兼职有几人: 人。 职人员。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 13 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 从事验收、养(150 查花名册、档案。在不同岗位学历是否符合规定: 护、计量和销1) 随机抽取1-2人检查学历是否符 是售工作的人员 合规定。 ?，否?; 应具有高中 如否，不符合规定的有几人: (含)以上文 人。 化程度。 (150企业从事验 查花名册、档案。在不同岗位是否经岗位培训并取得市局岗位收、养护、计2) 抽取1-2人检查是否经过培训，合格证书: 量和销售工作 并有市局核发的合格证书。 是的人员应经岗 ?，否?; 位培训和地市 如否，有验收、养护人员: 人，级(含)以上 销售人员: 人。 药品监督管理 部门考试合 格，取得岗位 合格证书后方 可上岗。 (150企业在国家有 查花名册、档案，随机抽取 是否取得职业资格证书: 就业准入规定2-3名采购员、销售员检查是否3) 是岗位工作的人取得职业资格证书。 ?，否?。 员，需通过职(现场检查时可根据当地劳动 业技能鉴定并部门规定，酌情掌握) 取得职业资格 证书后方可上 岗。 9 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A1914 企业从事质量(*15 管理、验收、04) 查相关文件、花名册、档案。 专职人员: 人; 养护及计量等 占企业职工总数的比例: %。 工作的专职人 员数量，应不 得少于企业职 工总数的4% (最低不得少 于3人)，并保 持相对稳定。 (160企业每年应组1、 查健康检查档案，包括: 织质量管理、 (1)企业档案:每年体检的是否每年进行健康检查: 1) 药品验收、养工作安排、体检的总人员名单、 是护、保管等直体检汇总表(含体检时间、检查?，否?; 接接触药品的机构、体检项目、总人员参检比如否，有几人: 人。 岗位工作的人例、合格人员比例、不合格人员是否建立了健康检查档案: 是员进行健康 名单)、 ?，否?。 检查，并建立对不合格人员采取的措施。 健康 (2)从花名册中抽取5人， 档案。 查个人档案:上岗体检表及资 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 15 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业发现患有料、每年体检表及资料、患病离(160 有无患病人员: 有精神病、传染岗、治疗、体检、再上岗资料(原2) ?，无?。 病或者其他可件)。 患病人员是否调离接触药品的岗能污染药品疾2、 健康检查时间:要求每年不 位: 病的患者，应少于一次，检查医院及检查项 是立即调离直接目以各市药监局规定为准。 ?，否?。 接触药品的岗 位。 (1701企业应定期对1、查培训教育档案，包括: 是否定期进行培训: 各类人员进行 (1)企业内部培训教育档案: 是) 药品法律、法培训教育制度、年度培训计划、?，否?; 规、规章和专历次培训方案(包括目的、时间、如否，未培训的有几人: 人。 业技术、药品地点、内容、教材、教师、培训是否建立了培训或教育档案: 知识、职业道对象、方法、考核)、培训记录 是德等教育或培及总结、培训考核结果及所采取?，否?; 训，并建立档的措施等。 询问: 人，熟悉: 人，不熟案。 (2)抽取不同岗位员工5人，悉: 人。 3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-16 企业从事质量查个人培训教育档案:培训教育(1702 从事质量管理人员共几人: 人。 管理的人员，登记表(即每年接受教育培训的) 质量管理人员是否接受省局组织每年应接受省记录:含组织单位、时间、地点、 的继续教育: 级药品监督管教师、培训教育主题、考核结 理部门组织的果)、学历、职称证明及历次培 是?，否?; 继续教育;从训教育考核证明(复印件)等资 如否，有几人: 人。 事验收、养护、料。 计量等工作的2、询问企业有关岗位人员，了人员，应定期解他对法律、法规和专业知识接受企业组织等的熟悉程度;(可与0502、的继续教育。0601、0604、0607、0801、1001、以上人员的继1202、2901、3001等条询问续教育应建立相结合) 档案。3、 查质量管理人员每年是否接 受省局组织的继续教育。 4、 查验收、养护、计量人员是 否定期接受企业组织的继续 教育(可与企业培训相结合) (180企业应有与经 查现场。 经营场所与规模是否相适应: 营规模相适应1) 是的营业场所及 ?，否?。 辅助、办公用 房。营业场所 明亮、 整洁。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 17 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业应按经营(*19 企业规模(上一年销售额): 规模设置相应01) 20000万元以上?， 5000的仓库，其面 查现场。 万元以上?， 积(为建筑面 5000万元以下?。 积)大型企业 仓库面积(?): 不低于1500平 1500?以上?， 1000方米，中型企 ?以上?， 业不应低于 500?以上?。 1000平方米， 小型企业不应 低于500平方 米。 (190库区地面平 查现场。 地面是否平整:是?，否?; 整，无积水和库区有无积水或杂草:有?，无2) 杂草，无污染?; 源。库区有无污染源: 有?，无?。 (190企业药品储存1、 现场察看库区划分是否合 作业区、辅助理。 3) “三区”是否分开或有有效的隔作业区、办公(1)储存作业区:库房、货场、 离措施: 生活区应分开保管员工作场所; 是一定距离或有(2)辅助作业区:验收养护室、 ?，否?。 隔离措施，装分装室等 装卸作业场所是否有顶棚: 是卸作业场所有(3)办公生活区:仓库办公室、 ?，否?; 顶棚。 宿舍、汽车库、食堂、厕所、浴 如否，发现几处: 处。 室等 -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA1218 “三区”是否分开一定距离或 有有效的隔离措施。 2、查装卸作业场所是否有顶棚。 (*19企业有适宜药 库房总面积: ?。 品分类保管和04) 温湿度符合要求的库房面积 符合药品储存 查现场和温湿度记录。 ?， 要求的库房。 本条与2103条结合起来查。 其中:常温库 ?，阴凉库 其中常温库温 O?， 冷库(柜) ?; 度为0C— O温湿度不符合要求的库房面积 30C，阴凉库温 ?， 度不高于20 O其中:常温库 ?，阴凉库 C，冷库温度为 OO?，冷库(柜) ?。 2C—10C ;各 库房相对湿度 应保持在45, 75%之间。 (190库房内墙壁、 查现场。 库房内环境是否都符合要求: 顶棚和地面光是?，否?; 5) 洁、平整、门如否，发现几处: 处。 窗结构严密。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 19 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 库区有符合规 查现场。 库区消防安全设施是否都符合要(190 定要求的消1、有无消防水龙头; 求: 6) 防、安全设施。 2、灭火器是否在有效期内 是?，否?。 如否，发现几处: 处。 (*20仓库应划分待 查现场。 是否划分了五库(区): 验库(区)、合1、 仓库是否划分了五库(区); 01) 是格品库(区)、2、 五库(区)应按色标管理要 ?，否?; 发货库(区)、求设有明显标志; “五库(区)”是否设有明显标志: 不合格品库3、经营中药饮片应有零货称取 是(区)、退货库专库(区); ?，否?。 (区)等专用 本条可与4102条结合起来 经营中药饮片是否设置了零货称场所，经营中查。 取专库(区): 药饮片还应划 是分零货称取专 ?，否?。 库(区)。以上 各库(区)均应 设有明显标 志。 (210仓库应有保持 查现场。 是否配备了底垫: 是 药品与地面之 五库(区)均应配底垫。 ?，否?; 1) 间有一定距离如否，未配备底垫的库(区)是: 的设备。 (210仓库应有避 查现场。 是否有避光、通风设备: 光、通风的设 仓库内应有避自然光措施和 是2) -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA1220 备。 通风设备。 ?，否?; 如否，发现几处: 处。 仓库应有检测 查现场(不合格药品库除外)。 (210 每个仓库是否都有温湿度检测设和调节温、湿1、 每个仓间至少配备一台温湿3) 备: 度的设备。 度检测仪，悬挂地点适宜，位 是?，置以检测记录人员双目平视 否?; 为宜。温湿度计应有计量部门 如否，有几个仓间无温湿度检测审验标志。 设备: 个。 2、 每个仓间应配置有效调节库 是否都有有效调节温湿度的设房温湿度的设备(如空调、制 备: 冷机、除湿机等，看 是?， 是否用、是否有效，按仓库 否?; 面积推算现有的设备能否将 如否，无有效调节温、湿度设备温湿度控制在GSP规定的范 的仓间是: 围内)。 常温库?，阴凉库?，冷库本条与1904条结合起来查。 ?。 (210仓库应有防 查现场。 每个仓库是否都有防尘、防潮、尘、防潮、防 检查是否有电猫、档鼠板、粘4) 防污染以及防虫、防鼠、防鸟等霉、防污染以鼠板、鼠夹等防、捕鼠工具及纱 设备: 是?，否?; 及防虫、防鼠、窗、灭蝇灯、除湿机等措施。(排 如否，有几个仓间无防鼠设备: 防鸟等设备。 风扇应配置防护百叶或纱窗)。 个，几个仓间无防虫、防鸟设备: 个。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 21 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 仓库应有符合 查现场。 每个仓库是否都有安全用电要求(210 安全用电要求1、照明电线应有套管，不得裸的照明设备: 5) 的照明设备。 露; 是 2、危险品库应安装防爆灯。 ?，否?; 如否，有几个仓间不符合要求: 个。 (210仓库应有适宜 查现场。 是否有拼箱发货的工作场所和工拆零及拼箱发1、 是否有拼箱发货的工作场所6) 作台: 货的工作场所和拼箱工作台及相应的设备; 是和包装物料等2、拆零后的药品是否放在零货 ?，否?; 储存场所和设架上; 包装物料是否有专门的储存场备。 3、包装物料是否有专门的储存 所: 场所。 是 ?，否?。 (*22企业储存特殊 查现场。 管理的药品的1、 房库应是砖混或钢混结构的01) 专用仓库应具无窗建筑; 专用仓库安全设施是否都符合规有相应的安全2、 基本设施牢固，具有抗撞击 定: 设施。 能力; 是?，3、 装有钢制保险房门，双门双 否?。 锁; 4、 备有防盗、防火、报警装置; 5、 专用仓库与110联网。 本条与4108条结合起来查。 9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-22 经营中药材及 查现场。 (2301 是否设置了中药标本室(柜): 中药饮片的应1、是否设置了中药标本室(柜); ) 是设置中药标本2、收集的标本数量应与经营规 ?，否?。 室(柜)。 模相适应。 (240企业应在仓库 设置与企业规1) 是否设置了验收养护室:是?，模相适应、符 否?。 合卫生要求的 验收养护室面积: ?。 验收养护室， 其面积大型企 业不小于50平 查现场。 方米;中型企 业不小于40平 方米;小型企 业不小于20平 方米。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 23 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业的验收养 (240 护室应配置千配备的验收养护仪器有: 2) 分之一天平、 千分之一天平?、 澄明 澄明度检测度检测仪?、 仪、标准比色 标准比色液?、 水 液等;企业经分测定仪?、 营中药材、中 紫外荧光灯?、 解剖镜 药饮片的还应或显微镜?。 配备水分测定 仪、紫外荧光 灯、解剖镜或 显微镜。 (240企业的验收养 是否有防尘、防潮设备: 护室应有必要3) 是的防潮、防尘 ?，否?。 设备。 (250企业对所用设 现场抽取3-5台设备(检查的 是否有检查、维修、保养记录: 施和设备应定设施、设备主要有:制冷机、空1) 是期进行检查、调器、除湿机及验收养护用仪器 ?，否?; 维修、保养并等)进行检查: 如否，有几台设施设备无记录: 建立档案。 1、 是否有检查、维修、保养记 台。 录; 是否有操作使用记录: 是 2、 操作使用记录; ?，否?; 3、 设施设备档案(内容包括购 如否，有几台设施设备无记录: 进时间、设备的说明书、保修 A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-24 单、安装说明书、电路图等)。 台。 可同3701条结合起来查。 是否建立了设施设备档案: 是 ?，否?; 如否，有几台设施设备无档案: 台。 (260企业分装中药 查现场及资料。 饮片应有符合1、 检查是否有专门的分装场1) 规定的专门场所，其面积能否满足分装作 是否有分装场所: 是?，所，其面积和业要求; 否?; 设备应与分装2、 应配备符合分装工艺要求的 分装场所的面积: ?; 要求相适应。 设施设备。如分装工作台、 是否有符合分装要求的设施设称量工具、容器等分装工具; 备: 3、 具备相应资质的分装操作人 是员; ?，否?; 4、 应建立完善的分装过程控制 是否建立了分装记录: 是?，记录; 否?; 5、分装后的饮片需经质量检验 分装合格的饮片包装是否有标合格后方可办理入库手续; 签: 6、每件分装合格的饮片包装， 是应有标签，包括品名、规格、 ?，否?。 原生产厂家、原生产日期、分 装单位、重量、分装时间、质 量结论等 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 25 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业分装中药(260 查现场。 分装室内环境是否符合要求: 饮片的固定分2) 是?，否装室，其环境 ?。 应整洁，墙壁、 顶棚无脱落 物。 (2701企业应制定能是否制定了进货程序: 是?， 够确保购进的否?; ) 从付款凭证、在库药品或相药品符合质量询问采购人员进货程序内容: 关记录中随机抽取5-10个品种要求的进货程条，能准确回答出 条。 (现场抽查品种时，可将购进、序。 验收、入库需抽查的品种合并抽 (*270企业进货应确 取)进行检查(从国家重点监控是否为合法企业生产或经营的药定供货企业的2) 地区企业购进的药品，应作为重品: 法定资格及质 点审查对象)，查相关资料和现 量信誉。企业 场，审查企业所购进药品的基本是?，否?; 购进的药品应 条件是否符合规定。 如否，发现几种从非法渠道购进为合法企业所 1、 是否制定了能够确保购进的的药品: 生产或经营的 药品符合质量要求的进货程种。 药品。 序; (*270企业进货应审购进的药品是否为合法的药品: 2、询问1-2名采购人员，是否核所购入药品是?，否?; 3) 清楚进货程序; 的合法性。 如否，发现几种: 种。 3、购进的药品(中药材除外) 是否为合法 -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA1226 企业进货应对是否对销售人员进行合法资格验(*270 企业生产或经营的药品(审与本企业进行证: 4) 查供货方证、照的合法性、一业务联系的供 是 致性，供货方证照是否在有效货单位销售人?，否?; 期内、是否超范围生产、经营员，进行合法 如否，发现几名: 名。 等); 资格的验证。 4、审查购进的药品合法性(应 (2705企业进货应按购进的药品是否执行 合同 劳动合同范本免费下载装修合同范本免费下载租赁合同免费下载房屋买卖合同下载劳务合同范本下载 中规定有法定批准文号，质量标准，购货合同中质的质量条款: ) 包装、标识应符合有关规定和量条款执行。 是储运要求，进口药品应有符合?，否?。 规定的、加盖了原供货单位质 (2801企业购进的药购进的药品(中药材除外)是否量管理机构原印章的《进口药品除国家未规有法定的批准文号和生产批号: ) 品注册证》、《进口药品检验定的以外，应 是报告书》或《进口药品通关单》有法定的批准?，否?; 的复印件，中药材应标明产文号和生产批如否，发现几种: 种。 地); 号。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 27 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业购进的进5、 审查供货单位销售人员是否(*280 进口药品是否有符合规定的进口口药品应有符有供货单位注明有效期的法2) 药品注册证和检验报告书: 合规定的，加人委托书、身份证复印件; 是?，否?; 盖了原供货单6、 审查购进的药品是否执行了 如否，发现几种: 种。 位质量检验机合同中规定的质量条款。 构原印章的 2802条与3506条结合起来 《进口药品注查。 册证》和《进 2803条与3502、3504、3505口药品检验报条结合起来查。 告书》复印件。 2804条与3507条结合起来 查。 (2803企业购进的药药品的包装和标识是否符合有关 品的包装和标规定和储运要求: ) 识应符合有关是?，否?; 规定和储运要如否，发现几种: 种。 求。 (2804企业购进的中购进的中药材是否标明产地:是 药材应标明产?，否?; ) 地。 如否，有几种: 种。 (*290企业对首营企1、 询问采购员1-2名，是否清 业应进行包括楚首营企业含义; 1) 采购员是否清楚首营企业定义: 资格和质量保2、 抽查10个供货企业(现场检 是证能力的审查时要善于发现首营企业，可 ?，否?。 核。审核由业从提交的相关资料中，如付款 是否对首营企业进行审核: 务部门会同质凭证、购进记录、验收记录等 是量管理机构共抽取)看是否按首营企业审 -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA1228 同进行。除审批，如果不是首营企业，需提?，否?; 核有关资料交现场检查之日起12个月前如否，发现几个首营企业未进行外，必要时应的经营记录，否则需提交首营审核: 个。 实地考察。经企业审核资料。 审核资料是否齐全: 审核批准后，3、 查首营企业审核资料(首营 是方可从首营企企业审批表): ?，否?; 业进货。 (1)审核内容:包括加盖首营如否，有几个企业: 个，缺 企业原印章的合法证照复印件、项有: 销售人员的法人委托书(须标明首营企业审批表?，合法证照复 授权范围及有效期)和身份证复印件?，销售人员合法资格证明 印件、首营企业GMP、GSP认?、GMP(或GSP)认证证书?(暂 证情况的有关证明。 不作强行要求)。 (2)审核程序:业务部门按规审核程序是否符合规定: 定将审核资料收集齐全后，填写 是 “首营企业审批表”?质管机构?，否?。 审核并提出明确审核 意见 文理分科指导河道管理范围浙江建筑工程概算定额教材专家评审意见党员教师互相批评意见 ?分 管质量负责人审批?业务部门 进货。 本条与0604条结合起来查。 (*300企业进货对首1、 询问采购员1-2名，是否清 营品种应填写楚首营品种含义; 1) “首次经营药2、 抽取10种药品(现场检查时 品审批表”，并要善于发现首营品种，可从采购员是否清楚首营品种定义: 经企业质量管提交的相关资料中，如付款 是理机构和企业凭证、购进记录、验收记录?，否?。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 29 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 主管领导的审等，或从在库商品中抽取)是否对首营品种进行审核: 核批准。对首看是否按首营品种审批，如 是营品种(含新果不是首营品种，需提交现?，否?; 规格、新剂型、场检查之日起12个月前的经如否，发现几个首营品种未进行新包装等)应营记录，否则需提交首营品审核: 个。 进行合法性和种审批资料。 审核资料是否齐全: 质量基本情况3、查首营品种审批资料(首营 是的审核，包括品种审批表): ?，否?; 核实药品的批(1)审核内容:包括加盖生产如否，有几个品种: 个，缺准文号和取得单位原印章的合法证照复印件，项有: 的质量标准，药品生产批准证明文件，质量标首营品种审批表?，合法证照复审核药品的包准，出厂检验报告书，药品包装、印件?，药品生产批准证明文件装、标签、说标签、说明书实样，了解药品性?，质量标准?，出厂检验报告明书等是否符能、用途、储存条件及质量信誉书?，药品包装、标签、说明书合规定，了解等; 实样?; 药品的性能、(2)审核程序:业务购进部门审核程序是否符合规定: 用途、储存条按规定将审核资料收集齐全后， 是件以及质量信填写“首营品种审批表”?质管?，否?; 誉等内容，审机构审核并提出明确审核意见 核合格后方可?分管质量负责人审批?业务 经营。 部门进货。 本条与0604条结合起来查。 9 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A1930 企业编制购货1、查购货计划(购货计划形式(3101 是否编制购货计划: 是计划时应以药有供货企业名单，购进品种目) ?，否?; 品质量作为重录，年度、季度、月份购进计编制计划是否有质量管理机构人要依据，并有划); 员参加: 质量管理机构2、 购货计划应经质量管理部门 是人员参加。 审核(应有明确审核结论)后，?，否?。 报分管质量负责人审批，由业 务部门实施。 (3201企业签定进货 抽取5-10个品种(可与2701 是否有合同: 合同应明确质条合并抽取)，查进货合同。(合) 是量条款。购销同的形式有:标准书面合同;传?，否?; 合同中应明真、电话记录等) 如否，有几个品种: 个。 确:药品质量1、是否有合同; 符合质量标准2、标准书面合同是否有明确的 和有关质量要质量条款; 求;药品附产3、采用传真、电话记录等非标合同中是否有明确的质量条款: 品合格证;药准书面合同形式时，购销双方 是品包装符合有应提前签订有明确质量责任?，否?; 关规定和货物的“质量保证协议”，并标明如否，发现几份合同: 份。 运输要求;购协议有效期限(期限不得超过 入进口药品，许可证的有效期限)。 供应方提供符 合同或质量保证协议应在进 合规定的证书货前签订，不能后补，否则视同 和文件。无合同。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 31 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 购进药品应有购进药品是否有合法票据: (*330 抽取5-10个品种(可与2701合法票据，并 是1) 条合并抽取)与查资料相结合: 按规定建立购?，否?; 1、进货是否有增值税票或普通进记录，做到如否，发现几个品种: 个。 发票; 票、帐、货相票、帐、货是否相符: 2、是否建立了购进记录(视企符。购进记录 是 业具体情况可与销售记录合应注明药品的?，否?; 并，也可在电脑中建立购进记品名、剂型、如否，发现几个品种: 个。 录); 规格、有效期、是否建立了购进记录: 3、记录内容是否完整; 生产厂商、供 是 4、查票、账、货相符，应做到:货单位、购进?，否?; 购进药品的数量=库存药品数数量、购货日如否，发现几个品种: 个。 量+已销售药品数量; 期等项内容。记录内容是否完整: 5、购进记录是否按规定保存; 购进记录应保 是存至超过药品?，否?。 有效期1年， 但不得少于3 年。 (3302购入特殊管理 查有关资料(文件)和现场。 是否具备经营资格: 的药品，应严1、 麻醉药品和一、二类精是?，否?; ) 格按照国家有神药品是否具有经营资格; 是否违反规定经营: 关管理规定进2、 购入药品时是否执行国是?，否?; 行。 家规定。 购入药品时是否执行国家规定: 是?，否?。 5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-32 企业每年应对(340 查进货质量评审资料。 进货情况进行1、 评审目的是否明确;(应对1) 是否每年对进货情况进行评审: 质量评审，评所经营药品质量进行综合评 是审结果存档备审、对比、分析，为购进决策 ?，否?。 查。 提供依据。) 2、评审部门:质量领导组织或 是否有评审报告: 质量管理机构会同业务部门 是 进行; ?，否?; 3、评审依据:管理制度、质量 评审报告是否符合要求: 信息、工作标准; 是 4、评审项目:应对验收合格率、 ?，否?。 储存的稳定性、销后退回情 况、顾客投诉情况、监督抽查、企业质量信誉等进行统计分析; 5、评审报告:要求内容、项目具体，结论明确。 (*350企业应严格按 抽取5-10个品种(可与2701 照法定标准和条合并抽取)。 1) 是否验收并有记录: 合同规定的质1、查验收组是否对每批药品均 是量条款对购进进行了验收，并有记录; ?，否?; 药品、销后退2、现场察看和询问验收人员如 如否，发现几批药品未验收: 回药品质量进何进行验收。 批。 行逐批验收， 本条应与0607、3502、3503、 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 33 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 并有记录。 3504、3505、3506、3507、3509、验收人员是否按验收管理制度验 3510、3511条结合起来查。 收: 是 ?，否?。 9 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A1934 验收时应同时 (3502 查在库药品并随机抽查5-10对药品的包 ) 个品种(可与2701条合并抽装、标签、说 取)。 明书以及有关包装、标签和说明书是否符合规 1、 药品的包装、标签和说明书要求的证明或定: 是否符合规定; 文件进行逐一 是 2、 整件包装中是否有产品合格检查。验收药?，否?; 证。 品包装的标签如否，发现几种药品不符合规定: 3502条与2803条结合起来和所附说明书种。 查。 上应有生产企 业的名称、地 址，有药品的 品名、规格、 批准文号、产 品批号、生产 日期、有效期 等; 标签或说明书 上还应有药品 的成分、适应 症或功能主 治、用法、用 量、 禁忌、不良反 应、注意事项 以及贮藏条件 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 35 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific等。 验收整件包装包装中是否有产品合格证: 是(3503 中应有产品合?，否?; ) 格证。 如否，发现几种药品无合格证: 种。 (3504验收特殊管理 特殊管理药品是否符合规定: 的药品、外用) 查在库药品，检查包装的标 是药品，其包装 签和说明书是否符合规定。 ?，否?; 的标签或说明 本条与2803条结合起来查。 外用药品是否符合规定: 书上有规定的 是标识和警示说 ?，否?; 明。处方药和 处方药和非处方药是否符合规非处方药按分 定: 类管理要求， 是标签、说明书 ?，否?; 上有相应的警 非处方药的包装是否有专有标示语或忠告 识: 语;非处方药 是的包装有国家 ?，否?。 规定的专有标 识。 3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-36 验收进口药(3505 是否有中文标签和和说明书: 品，其包装的) 是标签应以中文 ?，否?; 注明药品名 查资料和在库的进口药品如否，发现几种进口药品不符合称、主要成分 并随机抽查5个品种。 规定: 种。 以及注册证 1、检查包装的标签和说明书是 号，并有中文否符合规定; 说明书。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 37 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 验收进口药2、查是否有符合规定的注册证(3506 品，应有符合和检验报告书。 ) 是否有符合规定的注册证和检验规定的《进口 3505条与2803条结合起来 报告书: 药品注册证》查。 是和《进口药品 3506条与2802条结合起来 ?，否?; 检验报告书》查。 如否，发现几种进口药品不符合 复印件;进口 规定: 种。 预防性生物制 品 、血液制品 应有 《生物制品进口批件》复印件;进口药材应有《进口药 材批件》复印件。以上批准文件应加盖原供货单质量管理机构原印 章。 (3507验收中药材和 查验收记录和现场检查中药中药饮片应有) 是否有包装并附有质量合格的标材、中药饮片仓库相结合。 包装，并附有 志: 1、中药材和中药饮片是否有包质量合格的标 是装，包装上是否附有质量合格志。每件包装 3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-38 上，中药材标的标志; ?，否?。 明品名、产地、2、中药材每件包装是否标明了每件包装标识是否符合规定: 供货单位;中品名、产地、发货日期、供货 是药饮片标明品单位; ?，否?; 名、生产企业、3、 中药饮片每件包装是否标明如否，有几种中药材和中药饮片生产日期等。了品名、生产企业、生产日期。 标识不符合规定: 种。 实施文号管理本条与2804条结合起来查。 的中药材和中 药饮片，在包 装上还应标明 批准文号。 (3508验收抽取的样1、查现场。在合格药品库(区)，是否有开箱抽样验收标记: 品应具有代表检查3-5批购进未出库的整件 是) 性。 药品是否有开箱抽样标记; ?，否?; 2、请验收员演示抽样方法，判如否，发现几种药品无开箱抽样 定是否按照抽样规则进行抽标记: 种。 样。 验收员是否按照抽样规则抽样: 是 ?，否?。 (*350验收药品应做1、 按3501条检查方法查验收是否有验收记录: 是好记录。验收记录是否完整规范; ?，否?; 9) 记录应记载供2、 查验收记录是否按规定保如否，发现几个批号的药品无验货单位、数量、存; 收记录: 个。 到货日期、品说明:使用电脑记录或采用省局验收记录内容是否完整: 名、剂型、规印制的“三合一”台帐作为验收 是 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 39 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 格、批准文号、记录，须提交《入库验收通知单》?，否?; 批号、生产厂或其它原始验收记录，且上面记如否，有几个品种: 个，缺项商、有效期、载的项目应符合验收记录的要有: 质量状况、验求，并有明确的验收结论和验收供货单位?、数量?、到货日期收结论和验收员签章，否则视同未验收。 ?、品名?、剂型?、规格?、人员等项内 本条与3501条结合起来查。 批准文号?、批号?、生产厂商容。验收记录?、有效期?、质量状况?、验应保存至超过收结论?、验收人员?。 药品有效期1验收记录是否按规定保存: 是年，但不得少?，否?。 于3年。 (3510验收首营品 抽查5个首营品种验收记是否有该批药品的检验报告书: 种，应有该批录，核对首营品种的批号与索取 是) 药品的质量检的出厂检验报告书批号是否相?，否?; 验报告书。 同。 如否，有几个品种: 个。 本条可与3001条结合进行 检查。 (3511对销后退回的 从合格库或不合格库保管台是否进行验收并有验收记录: 凭业务部开具的 药品，验收人帐中抽取5个销后退回药品(可 是通知 ) 员按进货验收与4109条合并抽取)，查验收记?，否?; 的规定验收，录。 如否，有几种药品未验收: 种。 必要时应抽样 本条可与3501、4110条结合 送检验部门检起来查。 验。 A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-40 对麻醉药品、是否进行双人验收，并有记录: (*351 抽5个品种，查特殊管理药品一类精神药 是2) 验收记录。 品、医疗用毒?，否?; 性药品，应实如否，发现几种药品未双人验收: 行双人验收制种。 度。 (3513验收应在符合是否在规定场所和规定的时间内 现场察看与询问验收员相结规定的场所进验收完毕: ) 合。 行，在规定的 是 时间内完成。 ?，否?; 如否，有几种药品: 种。 验收员的回答是否与验收管理制 度相一致: 是 ?，否?; (360仓库保管员凭1、 抽5-10个品种(可与2701保管员是否凭验收员签字或盖章验收员签字或条合并抽取)查入库单:是收货: 1) 盖章收货。对否有验收员签字并有明确的 是货与单不符、验收结论，入库单中的数量?，否?; 质量异常、包与实际入库数量是否相符。 如否，有几种药品: 种。 装不牢或破2、 查在库药品，看是否有质量入库单数量与实际入库数量是否损、标志模糊异常、包装不牢或破损、标相符: 等情况，有权志模糊等情况; 是拒收并报告企3、查有关资料:拒收报告或质?，否?; 业有关部门。 量异常情况报告单。 如否，有几种药品货单不符: practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 41 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 种。 对质量异常、包装、标志有问题 的药品保管员是否拒收: 是 ?，否?; 如否，发现几种药品 种。 (3701用于药品验收是否建立了登记台帐: 是 1、查仪器、计量器具登记台帐; 养护的仪器、?，否?; ) 2、查养护仪器使用记录; 计量器具等，如否，有几种仪器无台帐: 种。 3、查计量器具检定记录和检定应有登记、使是否有使用记录: 是 证书。 用和定期检定?，否?; 可同2501条结合起来查。 的记录。 如否，有几种仪器、器具无记录: 种。 计量器具是否进行了定期检定: 是?，否?; 如否，有几台计量器具未定期检 定: 台。 -r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA1542 企业应对质量 查资料，并从不合格药品库 (4001 不合格药品进(区)或相关记录(台帐)中，发现不合格的药品是否按规定的) 行控制性管抽取5个不合格药品。 程序和要求上报: 理，发现不合1、 查不合格药品来源。根据来是?，否?; 格药品应按规源查有关环节和岗位是否按如否，发现几种: 种。 定的要求和程规定程序和要求报告质量管验收、养护人员是否清楚不合格 序上报。 理部门;质管部门是否对上报药品的处理程序: 的问题进行调查、分析、裁决，是?，否?。 并提出处理意见。 (*400不合格药品应2、分别询问验收员、养护员各是否专库(区)存放，并有明显 1名，是否清楚不合格药品的存放在不合格标志: 2) 处理程序。 药品库(区)， 3、查现场。检查不合格药品是并有明显标是?，否?; 志。 否专库 (区)存放，标识明如否，在其它库(区)发现几种: 显。 种。 4、查质量管理部门对不合格药 品是否查明原因，分清责任， 及时处理并制定出 (4003对不合药品应 相应的预防措施。 是否查明原因，分清责任，及时查明质量不合5、查记录:即报告、确认、报处理并采取预防措施: ) 格的原因，分损、销毁是否有完善的手续和是?，否?; 清质量责任，记录。 如否，发现几种: 种。 及时处理并制6、查麻醉药品、毒性药品、一 定预防措施。 类精神药品的销毁记录:是否 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 43 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 不合格药品的上报当地药监部门批准后，在报告、确认、报损、销毁是否有(*400 确认、报告、药监等有关部门监督下销毁。 完善的手续和记录: 4) 报损、销毁应7、 查不合格药品处理情况的汇是?，否?; 有完善的手续总和分析报告。检查质量管如否，发现几种不合格药品手续 和记录。 理机构是否定期统计并分析和记录不全或无记录: 种。 不合格药品原因，找出质量特殊管理药品是否在药监部门监 管理工作中存在的缺陷，改督下销毁: 进和完善质量管理工作; 是?，否? 。 4001条与0602、0606条结合 (4005对不合格药品起来查。 质量管理部门是否对不合格药品的处理情况应) 4003条可与5601条结合起来 的处理情况进行定期汇总、分析: 定期汇总和分查。 是?，否? 。 析。 4004条与0609条结合起来查。 (*410药品应按温、是否按照温、湿度要求储存于相 查在库药品。 湿度要求储存应库中: 1) 于相应的库 是?，否? ; 中。 如否，发现几种: 种。 (4102在库药品均实 行色标管理。) 其统一标准 查现场。 色标管理是否规范: 是:待验药品 “五库(区)”色标管理是否 是库(区)、退货规范。 ?，否? 。 药品库(区) 为黄色;合格 5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-44 药品库(区)、零货称取库 (区)、待发药品库(区)为绿色;不合格药品库(区)为红色。 (4103搬运和堆垛应 堆垛是否符合要求: 是严格遵守药品) 查现场。 ?，否?; 外包装图示标 1、 查药品堆垛是否符合要求; 如否，有几种药品堆垛不符合要志的要求，规 2、 查“五距”是否合理; 求: 种。 范操作。怕压 3、查近效期药品是否有明显标药品应控制堆 志。 放高度。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 45 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 药品与仓间地(4104 面、墙、顶、) 散热器之间应 “五距”是否符合规定: 有相应的间距 是或隔离措施。 ?，否?。 药品垛堆应留有一定的距 离。药品与墙、屋顶(房梁)的间距不小于30厘米，与库房散热器或供暖管道的间距不小于30厘米，与地面的间距不小于10厘米。 -A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 1246 药品应按批号(4105 近效期药品是否有明显标志: 集中堆放。有) 是效期的药品应 ?，否?; 分类相对集中 如否，发现几种药品无明显标志: 存放，按批号 种。 及效期远近依 次或分开堆码 并有明显标 志。 (4106对近效期的药1、 近效期药品的确定由企业根 是否按月填报效期报表: 品，应按月填据实际情况自主决定，写入制) 是报效期报表。 度; ?，否?; 2、 从在库商品中抽取5个近效 如否，发现几种近效期药品未按期药品，查是否按月填报效期 月填报: 种。 报表。 3、 查业务部门是否采取了催销 措施。 (*410药品与非药 查现场。 药品与非药品、内用药与外用药品、内用药与1、 对药品性质有影响的非药品是否分开存放: 7) 外用药应分开必须分库存放，如杀虫剂等; 是?，否?; 存放;易串味2、易串味的药品必须专库(必如否，发现有几种非药品与药品的药品、中药须独立空调、排风口向外); 混放: 种。 材、中药饮片3、中药材、中药饮片必须专库; 易串味的药品是否专库存放: 以及危险品等4、危险品必须专库。 是?，否?; 应与其他药品如否，发现几种易串味药品未专 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 47 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 分开存放。 库存放:种。 中药材、中药饮片是否专库存放: 是?，否?; 危险品是否专库存放: 是?，否?。 (*410麻醉药品、一 查看资料与现场检查结合。 特殊管理药品是否专库(柜)存类精神药品、1、麻醉药品、一类精神药品、8) 放: 医疗用毒性药医疗用毒性药品必须专库或 是品应当专库或专柜存放(其中:麻醉药品和 ?，否?。 专柜存放，双一类精神药品可同库分区存 是否做到双人双锁保管、专帐记人双锁保管，放)，双人双锁，专帐记录; 录: 专帐记录，帐2、二类精神药品:应专库存放， 是物相符。 库门加锁; ?，否?。 3、抽查3个品种，检查帐物是 账物是否相符: 是否相符。 ?，否?; 本条可与2201条结合起来 如否，发现几个品种帐物不符: 查。 个。 3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-48 对销后退回的是否专库(区)存放: 是(*410 查资料和现场，并从合格库药品，应凭经?，否?。 9) 或不合格库保管台帐中抽取5营部门开具的是否有退货凭证和退货记录: 个销后退回药品(可与3511条 退货凭证收 合并抽取)。 是?，否?; 货，存放于退 1、询问保管员、销售员各1名，如否，发现几种药品无退货凭证货药品库 是否清楚销后退回药品的管和退货记录: (区)，由专人 理程序; 种。 保管并做好退 2、查是否有退货凭证和退货记销售员、保管员是否清楚退回药货记录。 录; 品的管理程序: 3、查现场，销后退回药品是否是?，否?。 专库(区)存放; 销后退回的药(4110 保管员是否根据验收结论，将药品经验收合格4、查验收记录，根据验收结论) 品存入相应的库(区)(即:合格跟踪药品流向。 的，由保管人 库或不合格库): 4110条可与3511、4004条结员记录后方可 是合起来查。 存入合格药品 ?，否?; 库(区);不合 如否，发现几种药品未经验收就格的药品由保 存入合格库或不合格库: 种。 管人员记录后 放入不合格药 品库(区)。 (4111退货记录应保是否按规定保存: 是 存3年。 ?，否?。 ) practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 49 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 药品养护人员 查指导记录和现场。 (4201 是否进行指导: 是应指导保管人1、 询问保管员:养护人员如何) ?，否?; 员对药品进行对其进行指导，根据回答，判 在库药品是否合理储存: 是合理储存。 定是否指导; ?，否?。 2、 检查在库药品是否合理储 存。 (*420药品养护人员 查温湿度记录，并现场察看是否进行库房温湿度监测: 应检查在库药2) 和询问。 是?，否?; 品的储存条 1、 询问温湿度记录人员如何进每日上、下午是否定时对库房的件，配合保管 行库房温湿度监测及在温湿温、湿度进行记录: 人员进行库房 度超标的情况下如何采取措是?，否?。 温、湿度的监 施;节假日如何监测; 记录是否真实、完整: 是测和管理。每 2、 查温湿度记录是否真实完?，否?; 日应上、下午 整，如温、湿度超标，是否及温湿度超标是否采取了调控措各一次定时对 时采取了有效措施，并予以记施: 库房的温、湿 录。 度进行记录。 是?，否?; 3、查记录时间是否定时并具有企业库房温、 采取调控措施后温湿度是否符合代表性。 湿度超出规定 规定: 本条与1904条结合起来查。 范围，应及时 采取调控措 是?，否?; 施，并予以记 录。 (4203药品养护人员1、 查是否制订了中药材和中药是否制订了养护程序和方法: 应对中药材和饮片的养护程序和方法; ) 9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-50 中药饮片按其2、 查养护记录; 是?，否?; 特性，采取干3、 现场询问养护人员如何进行是否有养护记录: 燥、降氧、熏养护。 是?，否?; 蒸等方法养养护人员是否清楚养护方法: 护。 是?，否?。 (4204药品养护人员 查药品养护记录(在库时间 应对库存药品达到三个月的药品应列入养护) 是否有养护记录: 是根据流转情况之列，并做好记录)。 ?，否?。 定期进行养护1、 每季度是否按30%、30%、 是否有澄明度检查记录: 是和检查，并做40%的比例将库内药品循检 ?，否?。 好记录。 一遍; 养护员是否正确掌握澄明度检查2、 养护记录内容(包括:品名、 方法: 规格、生产企业、批号、批准 文号、有效期、数量、质量状 是?，否?。 况、养护措施、处理结果、检 查日期)是否完整; 3、 查澄明度检查记录; 4、 请养护员现场演示澄明度检 查方法。 (4205药品养护人员查养护记录、养护质量信息 对检查中发现等资料，核实养护中发现的问题) 是否及时上报质量管理机构复的问题应及时(包括技术操作、设施设备及药 查、处理: 通知质量管理品质量等方面的内容)是否及时 机构复查处上报质量管理机构复查、处理。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 51 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 理。 本条与0606、4209条结合起是?，否?。 来查。 (4206药品养护人员 查养护质量信息上报资料。 是否定期上报养护质量信息: 应定期汇总、内容应包括:汇总该经营周期内) 分析和上报养经营品种的结构、数量、批次等 是?，否?; 护检查、近效项目;统计并分析养护过程中发 质量信息的内容是否完整: 期或长时间储现的质量问题的相关指标(如质 存的药品等质量问题产生的原因、、比率等)， 是?，否?。 量信息。 改进的措施及目标。 (4207药品养护人员 查养护用仪器设备、器具是应负责养护仪) 是否明确有专人管理: 否明确有专人管理，并有台帐和器设备、温、 使用记录。 湿度检测仪 是?，否?。 本条与3701条结合起来查。 器、仓库在用 计量仪器及器 具等的管理工 作。 (4208药品养护人员 查药品养护档案，包括: 应建立养护档1、是否建立了养护档案; ) 是否建立了养护档案: 案。 2、建档品种(应是重点养护品 种:含首营品种、新品种、主 是?，否?; 营品种、质量不稳定品种、发 -3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C52 生过质量问题的品种等)应经建档品种是否经质量部门批准: 质量管理部门批准(每年调 是?，否?; 整); 3、档案内容(药品养护档案表、 重点养护品种确定表):包括 该品种的基本质量信息、观察 周期内对药品储存质量的追 踪记录、有关问题的处理情况 等内容。 (4209库存养护中发 查资料和现场。 是否准备了黄色标牌: 现质量问题，1、 从有关记录(如养护记录、) 应悬挂明显标不合格药品台帐等)中抽取3 是?，否?。 志和暂停发个养护检查中发现的有质量 是否及时上报质量管理机构处货，并尽快通问题的药品，查是否按规定 理: 知质量管理机报告质量部门处理; 构予以处理。2、 查库房内是否准备了黄色标 是?，否?; 牌。 如否，有几个质量问题未上报: 本条与4205条结合起来查。 个。 (4301药品出库“应是否遵循“先产先出”、“近期先 查现场和发货凭证。 先产先出”、出”和按批号发货的原则: ) “近期先出” 和按批号发是?，否?。 货 。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 53 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 企业在药品出(4302 库时，如发现) 企业发货时，是否做到有问题的以下问题应停 查现场和询问仓库保管员相药品不出库: 止发货，并报 结合。 是有关部门处 ?，否?; 理: 1、药品包装内 发现几种质量有问题的药品出有异常响动和 库: 种。 液体渗漏; 2、外包装出现 破损、封口不 牢、衬垫不实、 封条严重损坏等现象; 3、包装标识模糊不清或脱 落; 4、药品已超出有效期。 5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-54 药品出库复核(*440 抽查1个月的发货凭证和复时，应按发货1) 药品出库是否进行复核: 核记录。 凭证对实物进 是1、发货凭证上应有复核结论和行质量检查和 ?，否?; 复核人签名; 数量、项目的 如否，发现几个批号的药品未复2、出库复核记录内容是否完整; 核对。为便于 核: 个。 3、 特殊管理药品是否进行双人质量跟踪所做 复核记录内容是否完整: 是复核; 的复核记录， ?，否?; 说明:如果发货凭证上记载应包括购货单 如否，缺项有: 的项目符合复核记录的要求，可位、品名、剂 购货单位?、品名?、剂型?、用发货凭证代替复核记录。 型、规格、批 规格?、批号?、有效期?、生 如果企业使用电脑记录或采号、有效期、 产厂商?、数量?、销售日期?、用省局印制的“三合一”台帐作生产厂商、数 质量状况?、复核人员?。 为复核记录，须提交发货凭证，量、 且上面记载的项目应符合复核销售日期、质 记录的要求，并有明确的复核结量状况和复核 论和复核人员签章，否则视同未人员等项目。 复核。 (4402麻醉药品、一 是否进行双人复核: 类精神药品、) 是医疗用毒性药 ?，否?。 品出库时应双 人复核。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 55 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 复核记录应保(4501 是否按规定保存: 存至超过药品) 是有效期一年， ?，否?。 但不得少于三 年。 (4601对有温度要求 现场查看药品运输设备(车辆、是否具有保温或冷藏措施: 的药品的运) 保温或冷藏措施)。 是输，应根据季 ?，否?。 节温度变化和 运程采取必要 的保温或冷藏 措施。 (4701特殊管理的药1、现场查看:特殊药品和危险是否按有关规定办理: 品和危险品运品运输管理(如押运、封闭、 是) 输应按有关规加锁、悬挂标志等); ?，否?; 定办理。2、询问运输人员对特殊管理的运输人员是否清楚运输规定: 药品和危险品如何进行运输。 是?，否?。 (*480由生产企业直1、 从付款凭证或购销记录是否有验收记录: 调药品时，须中抽取5个直调药品，查验收1) 是?，否?; 经经营单位质记录。(不允许委托供方或需 如否，有几种药品无记录: 种。 量验收合格方方进行验收) 可发运。 (4901搬运、装卸药 查现场。 搬运、装卸药品是否符合规定: 品应轻拿轻) A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-56 放，严格按照 是?，否?。 外包装图式标 志的要求堆放 和采取防护措 施。 (4902药品运输时， 查现场和询问运输人员。 是否采取相应措施: 应针对运送药) 品的包装条件 是?，否?。 及道路状况， 采取相应措 施，防止药品 的破损和混 淆。 (*500企业应依据有 从销售记录或发货凭证中抽 是否将药品销售给具有合法资格关法律、法规取10个销售对象(重点抽查卫1) 的单位: 和规章，将药生所、诊所、零售药店或商场专 品销售合具有柜、性保健品店、国家重点监控 是?，否?; 合法资格的单地区的企业等)，审查其资质的 如否，发现几个无合法资格单位: 位。 合法性。 个。 (5101企业销售特殊 从销售记录或发货凭证中抽是否执行国家和我省的有关规 管理的药品应取5个销售对象，检查是否执行定: ) 严格按照国家国家和我省的有关规定。 是?，否?; 有关规定执 如否，发现几个销售对象无合法行。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 57 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 资质: 个。 (5201企业销售人员 现场询问销售人员。 是否正确介绍药品: 应正确介绍药) 是品，不得虚假 ?，否?。 夸大和误导用 户。 (*530企业销售药品是否开具合法票据: 应开具合法票1) 从发货凭证中，抽取5-10种是?，否?; 据，做到票、 药品，查: 如否，有几种药品未开具合法票帐、货相符。 1、是否开具增值税票或普通发据: 种。 销售票据应按 票; 票、帐、货是否相符: 是规定保存。 2、票、帐、货是否相符。 ?，否?。 nd IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA12-9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and anti58 企业应按规定3、是否有销售记录(视企业具是否建立了药品销售记录: (*530 建立药品销售体情况可与购进记录合并，也 是2) 记录。记载药可在电脑中建立销售记录); ?，否?; 品的品名、剂4、 记录内容是否完整; 如否，有几种药品无记录: 种。 型、规格、有5、 销售记录是否按规定保存。 记录内容是否完整: 是效期、生产厂?，否?; 商、购货单位、如否，缺项有: 销售数量、销品名?、剂型?、规格?、有效售日期等项内期?、生产厂商?、购货单位?、容。销售记录销售数量?、销售日期?。 应保存至超过记录是否按规定保存: 药品有效期一 是?，否?。 年，但不得少 于三年。 (5401因特殊情况需2、 查药品经营管理制度; 是否只是在特殊情况下从其它商要从其他商业3、 从付款凭证或购销记录中，) 业企业直调药品: 直调药品，本抽5个直调药品查验收记录。 企业应保证药(不允许委托供方或需方进 是?，否?。 品质量，并及行验收) 是否有验收记录: 时做好有关记说明:原则上不提倡药品直调经 录。 营，在企业制度中必须明确只有 是?，否?; 特殊情况(如重大疫情、抗洪救 如否，有几个直调药品无验收记灾等)才能直调。 录: 个。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 59 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific 药品营销宣传(5501 查现场。 广告是否经省局审批: 应严格执行国) 1、药品广告是否经省局审批(或家有关广告管 是?，否?; 备案); 理的法律、法 如否，发现几个非法广告: 个。 2、广告内容是否与批准内容相规，宣传的内 广告内容是否与批准内容相一一致; 容必须以国家 致: 3、是否有有奖销售宣传。 药品监督管理 部门批准的药 是?，否?。 品使用说明为 准。 (5601对质量查询、 查相关记录和资料。 是否查明原因、分清责任，并采投诉、抽查和1、 对发现的质量问题，是否查) 取处理措施: 销售过程中发明原因、分清责任，采取有 是现的质量问题效的措施; ?，否?; 要查明原因，2、 是否有记录。 是否有记录: 是分清责任，采 本条与0606、4003条结合起 ?，否?。 取有效的处理来查。 措施，并做好 记录。 (*570企业已售出的 根据国家局和省局药品质量有无质量公报品种: 有 药品如发现质公报，查企业相关资料。 ?，无?。 1) 量问题，应向1、 已售出药品是否及时追回; 是否及时追回并有记录: 有关管理部门2、 是否有记录。 是 报告，并及时?，否?; 追回药品和做如否，有几种质量有问题的药品 -9), and sugar Antigen 12-A199 (C-3), and sugar Antigen 19-3 (CA15-r logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15on (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumoerum logo real of determinatirelated projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b s-ological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunologyof biiochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different b a weekng, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice aboratory testing, clinical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testipractitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical lreactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific-Streptococcus hemolytic pigment "o" (AS O), c-irus antibody check (TORCH test) (5) other class: antind simple herpes vmitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, a-double chain DNA antibody (AdsDNA), and anti-nuclear antibody (ANA), and anti-t lymphocytes Asia group, and antind IgE), fill body determination (C3, and C4), like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, a-5), and prostate specific antigen (PSA), and p-5 (CA1260 好记录。未及时追回: 种。 (5702企业应按国家 查资料。 是否熟悉药品不良反应报告制度有关药品不良1、 询问质量管理机构负责人，) 规定: 反应报告制度是否熟悉国家有关药品不良 的规定和企业反应报告制度的规定; 是?，否?; 相关制度，注2、 是否印制了不良反应报告表 不良反应报告表格是否符合国家意收集由本企格; 规定: 业售出药品的3、 企业是否发现了不良反映情 不良反应情况，并按规定上报。 是?，否?; 况。发现不良 发现不良反映情况，是否按规定反应情况，应 进行了上报: 按规定上报有 关部门。 是?，否?。 practitioner examination practitioner certificate. Third stage: laboratory continues to rotate clinical laboratory testing, cli- 61 - nical chemistry, Clinical Immunology tests, Clinical Hematology laboratory, clinical microbiology testing, inspection and emergency blood transfusion test 7 Professional. (2) rounds and the third stage of consultation Web twice a week to attend medical ... To know: 1. automatic biochemical Analyzer calibration, operation and maintenance. 2. different biochemical detection of analyzers for test and evaluation. 3. the core collection, preservation and processing of all kinds of biological specimens. (E) professional master of Clinical Immunology test: 1. Clinical Immunology-related projects, the results of reports and clinical significance of routine testing. (1) hepatitis logo real: hepatitis b serum logo real of determination (HBsAg, and HBsAb, and HBeAg, and HBeAb, and HBcAb), and hepatitis a and hepatitis c virus antibody determination (2) tumor logo real: methyl tire protein (AFP), and cancer embryo Antigen (CEA), and sugar Antigen 15-3 (CA15-3), and sugar Antigen 19-9 (CA19-9), and sugar Antigen 12-5 (CA12-5), and prostate specific antigen (PSA), and p-like cell cancer related Antigen ( SCC) (3) immune function: immune globulin determination (IgG, and IgA, and IgM, and IgD, and IgE), fill body determination (C3, and C4), t lymphocytes Asia group, and anti-nuclear antibody (ANA), and anti-double chain DNA antibody (AdsDNA), and anti-mitochondrial antibody, and rheumatoid factor (RF) (4) virus antibody: bow insect, and rubella virus, and giant cell virus, and simple herpes virus antibody check (TORCH test) (5) other class: anti-Streptococcus hemolytic pigment "o" (AS O), c-reactive protein (CRP), serum Widal reaction, outside Pei, and cold agglutination test, specific