GAMP实验室计算机系统验证

GAMP实验室计算机系统验证 GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1 Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification. Over the past years I have not spoken in any great detail about guidance documents on computer validation for chromatographic systems and chromatography data systems (CDS) but concentrated on a specific topic from the regulations themselves. This is because most guidance has concentrated largely on computerized manufacturing and corporate systems, rather than laboratory systems. This has changed now with the publication of the Good Automated Manufacturing Practice (GAMP) Forum's Good Practice Guide (GPG) on Validation of Laboratory Computerized 1Systems. However, this publication needs to be compared and contrasted with the AAPS 2publication on Qualification of Analytical Instruments (AIQ). Both publications have been written by a combination of representatives from the pharmaceutical industry, regulators, equipment vendors and consultants. This will be a two-part discussion of the guide and where we should go to cover adequately both equipment qualification and validation of chromatography-based laboratory systems. GAMP指南为实验室计算机系统的验证，部分1 帮助调节在实验室用计算机系统的验证指导都是受欢迎的但是它总是有帮助吗, 在第一部分中，我提出的指导方法的概述，不同生命周期的验证和系统分类。 在过去的几年里我没有说任何伟大详细指导文件的计算机验证色谱系统和色谱数 据系统(CDS)但集中于从 制度 关于办公室下班关闭电源制度矿山事故隐患举报和奖励制度制度下载人事管理制度doc盘点制度下载 本身的主题。这是因为大多数的指导主要集中在 计算机制造业和企业系统，而不是实验室系统。 这与良好的自动化制造实践出版现在改变(GAMP)论坛的良好实践指南 (GPG)在实验室计算机系统的验证。1然而，本出版物需要比较与分析仪器资 格AAPs对比(AIQ)出版。2的出版物已被从制药行业监管机构的组合，代表写 的，设备供应商和顾问。 这将是一个指导两部分讨论，我们应该充分覆盖设备的资格和验证基于色谱实验 室系统。 1 Overview of the Guide Published in 2005, the stated aim of the GPG is to develop a rational approach for computerized system validation in the laboratory and provide guidance for strategic and tactical issues in the area. Section 5 of the GPG also notes that "...the focus should be on the risk to data integrity and the risk to business continuity. The Guide assumes that these 1two factors are of equal importance." The GPG notes that companies need to establish their own policies and procedures based on their own risk management approaches. Of interest, the inside page of the GPG states that if companies manage their laboratory systems with the principles in the guide there is no guarantee that they will pass an inspection — therefore caveat emptor! 在2005出 版，其目的是开发的GPG为实验室的计算机系统验证一个合理的方法，为在该地 区的战略和战术问题的指导意见。第5节的GPG还指出，―……应关注风险数据 的完整性和风险的业务连续性。本指南假设这两个因素是同等重要的。‖1 GPG指出，企业需要建立自己的政策，根据自己的风险管理方法的程序。感兴趣 的GPG状态，内页，如果公司管理实验室系统的原则指导没有保证他们会通过检 查-因此买者自负～ (AIQ)。2的出版物已被从医药行业，监管机构的组合代表写的，设备供应商和 顾问。 这将是一个指导两部分讨论，我们应该充分覆盖设备的资格和验证基于色谱实验 室系统。 The guide consists of a number of chapters and appendices as shown in Table 1. As you can see, the order of some of the chapters is a little strange. For example, why is the validation plan written so late in a life cycle or why is the chapter on training of personnel positioned after the validation report has been written? However, at least the main computer validation subjects are covered in the whole life cycle including system retirement. The Table 1: Contents of the GAMP GPG on GPG also cross references the main GAMP version 4 publication validation of for a number of topic areas for further information where laboratory systems. 3 appropriate. 2 本指南包括一些章节和附录表1所示。你可以看到，一些章节的顺序有点奇怪。 例如，为什么这样写在生命周期的后期验证计划或者为什么是位于后验证 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 写 好了人才培养的章,然而，至少主计算机验证主题的整个生命周期包括系统退 休。GPG也交叉引用主要GAMP 4版出版了一些进一步的信息在适当的领域3 One major criticism is that the nine references cited in Appendix 5 are very selective and, therefore, the GPG ignores some key publications in this area such as: , Furman et al. on the debate of holistic (or system) versus modular validation or 4qualification of computerized equipment. This paper was written by three FDA personnel about the validation of computerized chromatographic equipment; ignoring it is not an option as it provides a scientific rationale for this two-level approach. , PDA Technical Report 18 on validation of computer-related systems that contains a more specific computer validation definition than the FDA process validation 5,6definition quoted in Section 3.1 of the GPG. , AAPS Analytical Instrument Qualification white paper published in 2004, which was 2the outcome of a joint FDA-AAPS conference from 2003. , 一个主要的批评是，引用文献九篇附录5中是非常有选择性的和，因此， GPG忽略了一些关键的出版物在这方面如: , •弗曼等人。在整体的争论(或系统)与模块化验证或电脑设备的资格。4 本文由三FDA人员对计算机层析设备验证写;忽略它是不是一种选择，因 为它提供了这两个级别的方法科学的基本原理。 , •PDA技术报告18在计算机相关的系统，包含比FDA工艺验证定义引用的 GPG 3.1节更具体的计算机验证定义验证。5、6 , •AAPS仪器确认公布的白皮书中的2004，这是从2003.2个关节fda-aaps 会议的成果 Ignoring these papers biases the approach that this guide has taken and is a fatal flaw as we shall discuss later in this article. Overall, the problem with this GPG is that you have to cherry pick the good bits from the bad. As with any performance appraisal system, let's start with the good news first and work our way downhill afterwards. The Good News 3 The best parts of the GAMP laboratory system GPG are the life cycle models for both development and implementation of computerized 1laboratory systems. The writers of the guide are to be congratulated for producing life cycle models for development and implementation that reflect computerized systems rather than manufacturing and process 3equipment presented in the original GAMP guide. The latter V model life cycle is totally inappropriate for computerized and laboratory systems as it Figure 1: System bears little comparison with reality. The problem with the GAMP V model development was that immediately after programming the system it undergoes and system installation qualification (IQ). Unit, module and integration or system implementation life cycles testing is conveniently forgotten, ignored totally or implied rather than (adapted from explicitly stated. The two models illustrated in the laboratory GPG are the GAMP shown in Figure 1. The left-hand side shows the system development life laboratory GPG). cycle (SDLC) that is intended for more complex systems and the right- hand side which shows the system implementation life cycle (SILC) for simpler systems. This reflects the fact that we can purchase a system, install it and then operate it as shown on the right-hand of Figure 1. The vast majority of equipment and systems in our laboratories are similar to this, but consider the question: has the SILC oversimplified the implementation process for all spectroscopy and other laboratory computer systems? The argument for the SILC: For most computerized chromatographs and CDS in a post- Part 11 world, you will need to add user types and users to the system that will need to be documented for regulatory reasons, for example, authorized users and access levels required by both predicate rules and 21 CFR 11. However, after doing this for simpler systems, such as an integrator, we can go into the performance qualification stage; this is not mentioned specifically in the SILC. The argument against the SILC: The software used in some laboratory computerized systems may need to be configured — this is a term for either selecting an option in the software to alter its function within limits set by the vendor. This can be as simple as selecting which function will be used from two or three options or, in more complex systems such as a laboratory information management system (LIMS), using a language to set up a laboratory procedure or method. This factor is not accommodated specifically in either of the life cycle models. However, regardless of the approach taken, the system configuration must be documented partly for your business to allow reconfiguration of the system in case of disaster but also for performing the validation. ON划词翻译ON实时翻译 4 这反映了一个事实，我们可以购买一个系统，安装它，然后操作它，如 图1所示的右手。在我们的实验室，绝大多数的设备和系统是类似的，但考虑的问题:有SILC过于简单化的实施过程中的所有光谱和其他实验室的电脑系统, 的SILC的说法:在后部分11世界多数计算机色谱仪和CD，您将需要的系统，将需要记录的监管方面的原因，例如添加用户类型及用户，授权用户和访问级别所需的谓词规则和21 CFR 11。然而，在这个简单的系统，如一个积分，我们可以进入性能确认阶段;这是不是在SILC特别提到。 抗SILC的说法:在一些实验室计算机系统软件可能需要配置-这是一个选择一个选项的软件来改变它的功能在一定范围内的供应商的术语。这可以作为选择功能将从两个或三个选项或使用简单，在更复杂的系统，如实验室信息管理系统(LIMS)，用语言来建立一个实验室的程序或方法。这一因素是不适应具体的生命周期模型。然而，无论所采取的方法，系统的配置必须记录部分为您的企业可以在灾害情况下的系统重构也进行验证。 5 In my view, the concept of the SILC is good but the scope and extent of it can be taken further than the Laboratory GPG suggests. Furthermore, it can also be aligned with the existing software 3categories contained in Appendix M4 of the current GAMP Guide. The rationale is that many laboratory systems are configured rather than customized; therefore we need more flexibility than the simple SILC presented in the Laboratory GPG. This is where the GAMP Figure 2: Modified system software categories, outlined in Version 4 Appendix M4, come in implementation life and where the Laboratory GPG makes computer validation more cycle options and complex than it needs to be. macro development. 在我看来，这个概念是好的但SILC的范围和程度可比实验室GPG进一 步建议。此外，它还可以与现有的软件类别包含在附录M4当前GAMP 指南对齐。3的理由是，许多实验室系统的配置，而不是定制;因此我们 需要比在实验室GPG提供的简单SILC更多的灵活性。这是能在4版软 件类别，附录M4概述，进来在实验室GPG使计算机验证比它所需要的 要复杂得多。 Figure 2 is my attempt to take the SILC principles further than the GPG and align them with the existing GAMP software categories. A user requirements' specification is the entry point for all variations illustrated in Figure 2, the exit from this figure is the route to the qualification and configuration of the system. The definitions of the different types of GAMP software are , GAMP 3 software: This is commercial off-the-shelf software (COTS). The SILC for this type of software is shown on the right-hand side of Figure 2 In essence, this is a modification of the GPG implementation cycle where the documentation of security, access control and any other small software configurations for run time operation are substituted for the design qualification. 6 , GAMP 4 software: This is configurable commercial off-the-shelf software (configurable COTS). Once the software functions have been understood, an application configuration specification can be written that will state what functions in the software will be used, turned on, turned off or modified. After the software has been installed and undergone the IQ and operational qualification (OQ) has been performed, then the software can be configured according to the configuration specification documents. , GAMP 5 software: Although this is usually a unique and custom application. However, in the context of CDS software, this is typically a custom calculation, a macro or custom program that is written to perform a specific function. Therefore both GAMP 4 and GAMP 5 software can exist in the same system and the GAMP 5 aspects are typically an addition to the normal functionality of the software rather than a substitute. , 图2是我试图以SILC原则不是GPG进一步使其与现有的GAMP 软件类别。用户要求的规格是所有的变化，如图2所示为切入点， 从这个图的出口是系统设计的要求和配置路由。GAMP软件的不同 类型的定义是 , •GAMP 3软件:这是商用的现成(COTS)软件。这类软件的SILC 在右手边的图2所示的本质方面，这是一个修改的GPG实施周期的 安全文件，访问控制和其他小软件配置运行时操作代替设计资质。 , •GAMP 4软件:这是可配置的商用的现成(COTS软件配置)。一 旦软件的功能已经明白，一个应用程序的配置规格可写的，会在软 件状态什么功能将被使用，打开，关闭或修改。在安装软件后，经 7 历了智商和操作确认(OQ)已被执行，那么该软件可以根据配置文 件配置 规范 编程规范下载gsp规范下载钢格栅规范下载警徽规范下载建设厅规范下载 。 , •GAMP 5软件:虽然这通常是一个独特的，定制的应用。然而，在 CD的软件环境，这是一个典型的自定义计算，宏或自定义程序来完 成某个特定功能。因此，GAMP 4和GAMP 5软件可以在同一系统 中存在和GAMP 5方面通常是一个除了软件的正常功能，而不是一 个替代品。 Therefore, the life cycles for a CDS in this category will be the GAMP 4 software (central flow in Figure 2) plus the additional steps for GAMP 5 macros or calculations (pictured on the left-hand side of the same diagram). Here, there needs to be a specification for the macro (name plus version number), the calculation or the programming or recording of the macro. Against this will be formal testing to ensure that the functionality works as specified. Once this has been performed, then the macro is installed with the application and it is tested under the performance qualification (PQ) phase of validation as an integral part of the overall system. ON划词翻译ON实时翻译 因此，在这类的CDS的生命周期将GAMP 4软件(图2中的流动)加 上额外的步骤GAMP 5宏或计算(在同一图左边图)。在这里，我们需 要为宏观的规范(名称和版本号)，计算或宏编程或记录。在此将正式的 测试以确保功能作为指定。一旦这个已经完成，那么宏观安装的应用和它 8 所表现的是条件下测试(PQ)阶段的验证作为整个系统的一个组成部 分。 The Bad News Here, in my view, is where the GPG creates problems rather than solves them. My rationale is that computer validation is considered difficult by some people — therefore conceptual simplicity is a key issue for communication and understanding to ensure that we do not do more than is necessary, dependent on the risk posed by the data generated by a system. In the words of Albert Einstein: keep it as simple as possible — but no simpler. Don't look for simplicity in certain sections of this guide as it's not there. 坏消息 在这里，在我看来，就是GPG创造而不是解决他们的问题。我的理由 是，计算机验证是由一些人因此概念的简单性是沟通和理解，以确保我们 不超过一个关键的问题是需要考虑的困难，依赖于由系统生成数据的风 险。在艾伯特爱因斯坦的话:保持尽可能的简单但不简单。不要期待在本 指南中的某些部分，简单，它不存在。 Do We Validate or Qualify? There is always a debate in the laboratory between qualification or validation of laboratory equipment and computerized systems. Section 3.1 of the GPG discusses the qualify equipment or validate computer systems debate; it proposes to simplify the approach by classifying all equipment and systems under the single topic of "validation". However, this goes against how the rest of the organization works; it is important to emphasize that 9 laboratories are not unique islands inside an organization — rather they are an integral component of it. The inclusion of ANY item of laboratory equipment with a computer chip from a pH meter (GAMP Category 2 software upwards as a "computerized laboratory system" is wrong, in my view, as it will create much confusion. Especially as it goes against the advice of the GAMP Guide in Appendix M4, which states that the validation approaches for Category 2 systems consist of qualification steps or activities. Therefore, we now have conflicting guidance from the same organization on the same subject — you can't make this stuff up! The GPG is doubly wrong following the publication of the draft general chapter <1058> titled Analytical Equipment Qualification for the US Pharmacopeia as it kills the rationale 7for including everything under the term validation dead. I will discuss this publication under the AAPS AIQ in part two of this column. 我们验证或限制, 我们都有一场辩论在实验室之间的资格或验证的实验室设备和计算机系 统。3.1节讨论的GPG资格验证设备或计算机系统的争论;提出了简化 的方法进行分类，所有设备和系统在单一的主题―验证‖。然而，这违背了 其余的组织工作;它是强调实验室不独特的岛屿内的一个组织，而他们是 不可或缺的重要组成部分。 一个从pH计的计算机芯片的任何项目的实验室设备包含(GAMP 2类软 件向―计算机实验室系统‖是错误的，在我看来，这将创造更多的困惑。特 别是因为它违背了附录M4 GAMP指南的建议，即2类系统由合格的步骤 10 或活动的验证方法。因此，我们现在有冲突的指导，在同一标的同一个组 织不能使这东西了～ GPG是错的草案一般章,1058,发表题为分析设备的资格的美国药典作 为杀人的理由包括长期验证下死了一切。7我将讨论在第二本专栏的 AAPS AIQ在此发布。 Therefore, let us get the terminology right. We qualify , instruments , equipment We validate , systems , processes , methods We also calibrate , instruments , equipment. These simple principles are easy to grasp and allow any laboratory full flexibility to be made of the risk-based approaches to regulatory compliance. You do not usually need to do as much work to qualify an instrument for an intended purpose as you would validate a computerized system. In overview, the reason is that typically you'll need to qualify the instrument, as well as validate the software, which implies more work because it's usually a more complex system. Is this separation of "qualify equipment" and "validate systems" too simplistic? Yes for two reasons: 11 因此，让我们得到正确的术语。我们有资格 •仪器 •设备 我们验证 •系统 •过程 •方法 我们还可以校准 •仪器 •设备。 这些简单的原则是易于掌握和充分的灵活性，允许任何实验室进行合规性的基于风险的方法。你通常不需要做很多工作来获得一个目的的仪器可以验证一个计算机系统。在概述，原因是，通常你需要合格的仪器，以及验证软件，这意味着更多的工作，因为它通常是一个更复杂的系统。 12 这是―合格的设备‖和―验证系统―太过简单分离,有两个原因: 1. Do we have clear and agreed definitions of "laboratory equipment" and "laboratory system"? No. 2. Have we forgotten that all CDS have both the instrument (equipment) and system components (computer and training elements)? You can't operate the equipment without the system and vice-versa. Therefore, we need an integrated approach to these two issues which will be discussed in part two of this column. The debate is also clouded by the lack of suitable definition of "qualification". It is a difficult word to define as it is used in a variety of ways such as in design, installation, operational and performance qualification. A definition for qualification is defined in ICH Q7A GMP for active pharmaceutical ingredients as Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly and actually lead to the expected results. Qualification is part of 8validation, but the individual qualification steps alone do not constitute process validation. The first part of the definition is fine for equipment but the qualifying (sorry!) sentence means that here qualification is inextricably linked to validation. So we have a problem. However, a PIC/S guidance document with the snappy title of Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning 9Validation has some thoughts on the qualification versus validation debate: 2.5.2: The concept of equipment qualification is not a new one. Many suppliers have always performed equipment checks to confirm functionality of their equipment to defined specifications, both prior to and after installation. So for the purposes of our discussion we can start to tease out what a qualification process actually is: , Equipment is specified by the laboratory , Installation is properly undertaken , Equipment works correctly. 13 Of course, all stages are associated with appropriate documentation. We must also consider the requirements of the GMP regulations under ?211.160(b) for 10scientific soundness: Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling and drug products conform to appropriate standards of identity, strength, quality and purity. Therefore, the specifications for equipment and/or computerized systems and the tests used to qualify or validate them should be grounded in good science and include where necessary the use of traceable reference standards. Therefore, don't forget the impact of calibration: either on a formal basis against traceable standards (typically after a chromatograph has been serviced) as well as on a regular basis before a system is being used to make a measurement, for example, system suitability test. This all adds up to scientific-based control of the system, the chromatograph and potentially also a method. 1。我们有明确的和一致的定义的―实验室‖和―实验系统‖,号 2。我们已经忘记了所有的CD都该仪器(设备)和系统组件(计算机培 训要素),你不能操作该设备没有系统，反之亦然。因此，我们需要这两 个将要讨论的问题在第二本专栏的一个集成的方法。 这场争论也受到缺乏合适的定义的―资格‖。这是定义它是用来以各种方 式，如设计，安装一个难词，操作和性能的资格。资格的定义是指在ICH Q7A活性药物成分的GMP 14 证明和记录设备或辅助系统安装正确的行动，正确的工作确实产生预期的结果。确认是验证的一部分，但单独的确认步骤不构成工艺验证。8 第一部分的定义为设备优良但排位赛(对不起～)句子的意思，这里有着千丝万缕的联系，确认资格。所以我们有一个问题。然而，一个PIC/S指导文件的验证主计划的时髦书名，安装和操作资格，非无菌工艺验证，清洁验证有资格与验证的辩论的一些思考:9 2.5.2:设备的资格并不是一个新概念。许多供应商都确认自己的设备功能定义的规范进行设备检查，无论之前和之后的安装。 因此，我们讨论的目的，我们可以开始梳理实际上是一个合格的流程是什么: •设备是由实验室指定 •安装正确进行 •设备正常工作。 当然，所有的阶段与文档相关的。 我们还必须考虑的GMP法规要求下?211.160(B)为科学性:10 15 实验室控制应包括科学合理和适当的规格， 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 的建立，抽样计划和测试 程序的设计保证成分，药品容器，瓶盖，使用的材料，标签和药物产品符 合相应标准的身份，强度，质量和纯度。 因此，规格的设备和/或电脑系统，用来验证或验证测试应基于良好的科 学，包括在必要时可溯源的参考标准的使用。 因此，别忘了校准的影响:无论是一个正式的基础上，对可追溯的标准 (通常在一个色谱已提供服务)以及定期在一个系统被用来进行测量，例 如，系统适用性试验。这一切都增加了基础科学的系统控制，色谱和潜在 的一种方法。 Categorization of Laboratory Systems 1Section 2 of the Lab GPG notes: In GAMP 4, systems are viewed as a combination of individually categorized software and hardware elements. The proposed approach in this Guide is that Laboratory Computerized Systems can be assigned a single classification based upon the technical complexity of the system as a whole and risk to data integrity. In Appendix M4 of the GAMP Guide is a classification of software into five categories from operating systems (Category 1) to custom or bespoke software (Category 5). This is shown in Figure 3 on the left-hand side. Note, as we have discussed earlier, that more than one class of software can exist in a system; for example, GAMP Categories 1 and 3 for a basic CDS integrator commercial off-the-shelf package running on a PC plus Category 2 firmware within the chromatograph. 16 In an attempt to be all-encompassing for laboratory systems, the GPG has included ALL instruments, equipment or system with software of any description. Instead of five categories of software, we now have seven (Categories A to G). The categories that have been devised for the Laboratory GPG are based on four principles: 1. Configuration: The software used in the system varies from firmware that cannot be modified, to parameterization of firmware operating functions, proprietary configurable elements up to bespoke software (these are encompassed in GAMP version 4 software categories 2–5). 2. Interfaces: From stand-alone instruments to a single interface to another system and through to multiple interfaces to the system. 3. Data processing: From conversion of analogue to digital signals to post-acquisition processing. 4. Results and data storage: From no data generated to methods, electronic records and post-acquisition processing results. However, the approach outlined in the GPG is wrong again as it separates and isolates the laboratory from the rest of the organization when in reality it is an integral part of any regulated operation from R&D to manufacturing. We cannot have an interpreter at the door of the laboratory who interprets the GAMP categories used in the rest of an organization to Lablish (Laboratory computerized system validation English). There needs to be a single, unified approach to computerized system validation throughout an organization at a high level that acknowledges that there will be differences in approach as one gets closer to the individual quality systems, for example, GMP, GLP etc., and the individual computer systems. To do otherwise is sheer stupidity. Do You Really Want to Validate a Dishwasher? Some of the typical systems classified by the GPG are shown in Figure 3 on the right-hand side. In contrast, the left-hand side and centre columns show how systems from the traditional GAMP software categories map to the new GPG categories. You'll also note that a system can be classified in more than one GPG class depending on the software functions. In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as "laboratory computerized systems". Strictly 17 speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function. According to the main GAMP Guide all these items of equipment would be classified as Category 2 and "qualified" as fit for intended use. Under the Laboratory GPG, they are split into two classes (A and B) and are "validated" as fit for purpose. The comparison of the GAMP Guide and the Laboratory GPG software classifications are shown in Figure 3 on the right-hand side of the diagram and the arrows in the middle indicate how the two classification systems are mapped and are compared with each other. The horror that some of you may be having now around the suggestion to validate a balance, pH meter or centrifuge is more about terminology used rather than the work that you would do. Moreover, as we get to more complex laboratory systems such as LIMS the Laboratory GPG suggests that GAMP 4 categories may be more suitable! It really depends on the functions that the equipment or system does and how critical it is. Table 2 shows the comparison between the GAMP guide and the GPG for classifying typical laboratory systems; in the latter instance, HPLC with or without a data system in two or three categories. Looking at most of today's CDS it is difficult to imagine that some can fit into Lab Category C and D (equivalent to GAMP Category 3) as shown in Table 2. The main CDS systems used with a regulated laboratory must be configured to work correctly. This coupled with their use either to release or develop product means are high profile systems in any inspection. If there is any doubt look at the Able Laboratories inspection of May 2005 to see how a company collapsed after an FDA inspection of its 11CDS. In addition, regulated CDS systems can have custom calculations input — these are unique to an individual laboratory or organization and must be validated as such. 实验室系统1categorization 实验室的GPG讲稿2:1 在多糖4，系统被看作是一个单独的软件和硬件相结合的分类单元。所提 出的方法在本指南是实验室的计算机系统可以被分配一个基于系统的复杂 的技术作为一个整体和单风险分类数据的完整性。 18 附录M4的GAMP指南是一个软件的分类，从操作系统的五类(1类)定制的或定制的软件(5类)。这是在图3左侧所示。注意，正如我们前面所讨论的，一个以上的类软件可以存在于一个系统;例如，GAMP分类1和3的一个基本的CdS积分器的现成的商业包装在PC加类2固件在色谱运行。 在试图包罗万象的实验室系统，包括了所有的GPG仪器，设备或系统的任何描述软件。而五类软件，我们现在有七(类别A到G)。已经被设计为实验室GPG类别是基于四个原则: 1。配置:系统中使用的软件，固件，无法修改的变化，对固件操作功能的参数化，专有的配置元素的定制软件(这些都包含在4版软件类别2–GAMP 5)。 2。接口:从单机仪表一个接口到另一个系统，通过多个接口的系统。 3。数据处理:从模拟到数字信号的转换，收购后的处理。 4。结果和数据存储:从没有数据生成方法，电子记录和收购后的处理结果。 19 然而，该方法在GPG概述又错了因为它分离株从其他组织的实验室时，实际上它是制造任何规范的操作从研发的一个组成部分。我们不能在实验室的人解释用一个组织的休息lablish能类门翻译(实验室计算机系统验证英语)。需要有一个单一的，统一的方法来验证计算机系统在一个组织在一个高层次的承认，会有办法的差异作为一个接近个人品质系统，例如，GMP，GLP等，与个人计算机系统。否则，是十足的愚蠢。 你真的想验证一个洗碗机吗, 一些典型的系统由GPG分类图3右边所示。相反，左手边和中心列说明了系统如何从传统的GAMP软件类别映射到新的GPG类别。你也会注意到，一个系统可以被分为多个GPG类根据软件的功能。在设计这个分类系统，GPG提出了包括天平，pH计，离心机和玻璃垫圈为―实验室计算机系统‖。严格地说这是正确的-上面提到的所有设备的固件或ROM芯片，使系统功能。 主要根据GAMP指南，所有这些项目的设备将被归为2类，―合格‖适合预期用途。实验室环境下，可以分为两类(A和B)和―验证‖的适用。的GAMP指南和实验室GPG软件分类的比较图3中的图的右侧和中间的箭头表明这两个分类系统映射和相互比较。 20 恐怖，你们中的一些人可能已在建议来验证一个天平，pH计或离心机是 更多关于使用的术语而不是工作，你会怎么做。此外，我们得到的更复杂 的实验室系统如LIMS实验室GPG说明GAMP 4类可能更合适～这真的 取决于设备或系统的功能，这是多么重要。 表2显示了GAMP指南和典型的实验室系统分类的GPG的比较;在后 一种情况下，高效液相色谱法或无两或三类数据系统。看今天的大多数 CD很难想象一些能够适合实验室的C类和D(相当于GAMP分类3)如 表2所示。用一个稳压实验室主要的CDS系统必须配置正确工作。这与 他们使用释放或开发产品是指高级系统在任何检查。如果有任何疑问，看 看2005五月能力实验室检查看看一个公司倒闭的另外的cds.11 FDA的 检查后，调节光盘系统可以自定义计算输入-这是一个工业独特 Summary In today's risk- based environment, computer validation and equipment should be getting easier, quicker and simpler. Although the GAMP GPG for laboratory computerized systems was published in 2005, it reads as if it were published under the older and more stringent regulatory approach that existed before 2002 and FDA's Pharmaceutical Quality Initiative in 2004. The great concept is the system implementation life cycle and a realistic (at last!) system development life cycle as the good points from this document. In the next column, I'll look at the risk assessment methodology outlined in the guide, work by the AAPS and the USP on equipment qualification and a proposed way forward. 21 Robert McDowall is principal at McDowall Consulting, Bromley, Kent, UK. He is also a member of the Editorial Advisory Board for LCGC Europe. References 1. GAMP Forum Good Practice Guide — Laboratory Systems; International Society for Pharmaceutical Engineering: Tampa, Florida, USA (2005). 2. S.K. Bansal et al., Qualification of Analytical Instruments for Use in the Pharmaceutical Industry: A Scientific Approach (American Association of Pharmaceutical Scientists, USA (2004). 3. Good Automated Manufacturing Practice (GAMP) guidelines version 4, International Society for Pharmaceutical Engineering: Tampa, Florida, USA (2001). 4. W. Furman, R. Tetzlaff and T. Layloff, JOAC International 77, 1314–1317 (1994). 5. Validation of Computer-Related Systems, Parenteral Drug Association Technical Report 18, 1995 (Journal of the PDA , 49 S1-S17). 6. FDA Guidance on Process Validation Guidance (1987) 7. Pharmacopoeal Forum, <1058> Analytical Equipment Qualification, January 2005. 8. ICH Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients (2000). 9. Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation PIC/S Guide PI 006-1 PIC/S Geneva (2001). 10. FDA Current Good Manufacturing Practice for Finished Pharmaceutical Products (21 CFR 211) (1978). 11. R.D. McDowall, Quality Assurance Journal, 11(1), (2006). Comments on the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 2 In the second part of this article I will discuss risk assessment methodology, the new US Pharmacopeia general chapter <1058> and suggest an integrated approach to instrument qualification and computer validation. 22 1In the first part of this article we discussed the GAMP Good Practice Guide (GPG) for the 2Validation of Laboratory Computerized Systems. We looked at the advantages offered by the System Implementation Life Cycle (SILC) in contrast to the complexity of the system classification proposed in the GPG. In this part I'll look at the risk assessment methodology, the new US Pharmacopeia (USP) 3general chapter <1058>, which is based upon the AAPS analytical equipment 4qualification white paper, and suggest a way forward to unite the qualification of equipment with the validation of the controlling laboratory computers. 在GAMP指南为实验室计算机系统的验证的评论，2部分 在本文的第二部分，我将讨论的风险评估方法，新的美国药典通则< 1058 >和建议的综合方法对仪器条件和计算机验证。 在这第一条第一部分我们讨论了GAMP指南(GPG)为实验室计算机系 统的验证。2我们看着被系统实施生命周期所提供的优势(SILC)相对于 在GPG提出的系统分类的复杂性。 在这一部分，我会看的风险评估方法，新的美国药典(USP)总章, 1058,，3是基于AAPS分析设备的资格的白皮书，4和建议的方式提出 联合设备的资格与控制实验室计算机验证。 Risk Assessment Methodology 23 OK, if you managed to get this far after reading Part 1, we now have the 5finishing touch — the risk assessment methodology. GAMP 4 uses a modified Failure Mode Effect Analysis (FMEA) risk assessment methodology 3as outlined in Appendix M3. This has also been adapted for laboratory systems in the GPG. Why this over complex methodology was selected for laboratory systems is not discussed although I suspect that it is aimed at consistency throughout the GAMP series of publications. The overall Figure 1: GAMP GPG process flow for the risk assessment is shown in Figure 1: the first three risk steps are at the system level and the last two at the individual requirement management process. level. 风险评估方法 好吧，如果你设法到这么远，在阅读部分1，我们现在有画龙点睛的风险 评估方法。GAMP 45使用了修改后的故障模式影响分析(FMEA)风险 评估方法的概述附录m3.3这也适于在GPG实验室系统。为什么在这个 复杂的方法的选择实验室系统不讨论虽然我怀疑它是针对整个刊物 GAMP系列的一致性。风险评估的整体流程如图1所示:前面三步是在 系统级和个人需求水平的最后两个 FMEA was originally developed for risk assessment for new aeroplane designs in the late 1940s and has been adapted over time to encompass new designs and processes. However, as the majority of laboratory equipment and software used in laboratories is commercially available and purchased rather than built from scratch why is this inappropriate methodology being applied? Commercially available instruments and systems have already been tested by the vendors which can be verified by audits. Therefore, why should a risk analysis methodology that is very effective for new designs and processes be dumped or foisted on laboratories using mainly commercial systems? There are alternative and simpler risk analysis approaches 24 that can be used for the commercial off-the-shelf and configurable COTS software applications used throughout laboratories. For example, there are also , Hazard analysis and critical control points (HACCP) , Functional risk assessment (FRA). A detailed discussion of risk management is outside the scope of this column but I have written a recent paper on the subject that some of you may find useful as it compares the 6 various methodologies available. FMEA最初是在20世纪40年代后期的新飞机的设计风险评估和已经适 应随着时间的推移，包括新的设计和加工。然而，作为用于实验室实验设 备和软件的大部分是市售和购买而不是从无到有，为什么这是不恰当的方 法被应用, 市售的仪器和系统已经通过这一点可以通过审核供应商测试。因此，为什 么一个风险分析方法是非常有效的新的设计和工艺应倾倒或强加给主要使 用商业系统实验室,有种简单的风险分析方法，可用于商用用于整个实验 室架和可配置的COTS软件的应用。例如，也有 •危害分析和关键控制点(HACCP) •功能风险评估(FRA)。 风险管理的详细讨论在本专栏的范围，但我写过有关最近的一篇文章，有 些人可能会觉得有用的比较不同的方法。6 25 The GPG uses a Boston grid for determining system impact 2that is outlined in Appendix 1 of the document. However, because there are seven classes of laboratory Table 1: GAMP GPG for instrumentation and five classes of business impact this laboratory systems — requires a 7 × 5 Boston grid. This over complicates the issue system impact table and is NOT easily manageable (Table 1). Moreover, because some systems can be classified in a number of laboratory categories there is a possibility 1 that the impact of a system can be underestimated. GPG使用波士顿网格确定系统的影响，在文档的附录1中列出。2然 而，由于有七类实验室仪器和五类业务的影响，这需要一个7×5波士顿 网格。在这个复杂的问题，是不容易管理(表1)。此外，由于一些系统 可以分为多个实验室的类别有可能对系统的影响可以被低估了1。 Testing Approach versus Intended Purpose Throughout the GPG there appears to be an emphasis on managing regulatory risk. This is in contrast to the introductory statements in the GPG mentioned at the start of this column. From my perspective, this is wrong and emphasis should be placed on defining the intended purpose of the system and hence functions of the instrument and software that are required first and foremost. Only then will you be able to assess the risk for the system based on the intended functions of the system. The testing approach outlined in Sections 10 (Qualification, Testing and Release) and Appendix 2 need to be viewed critically. Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: , Verification of user SOPs , Capacity testing (as required) , Processes (between input and output) 26 , Testing of the system's back-up and restore (as required) , Security , Actual application of the system in the production environment (e.g., sample analysis). , 测试方法与目的 , 在整个GPG似乎在管理风险监管的重点。这是在对比中在本专栏开 始提到的GPG的介绍性发言。从我的角度来看，这是错误的，应将 重点放在定义系统的目的，因此该仪器和软件所需的首要功能。只 有你能评估基于预定的功能系统的风险。 , 10节中列出的测试方法(资格，测试和发布)和附录2需要批判地 看待。10节指出，测试或验证用户的要求对PQ操作，以下是常做 的: , 用户程序•验证 , •能力测试(如需要) , •过程(输入和输出之间) , •系统的备份和恢复的测试(如需要) 27 , •安全 , 在生产环境中的系统•实际应用(例如，样品分析)。 Appendix 2 covering the testing priority is a relatively short section that takes each requirement in the URS and assesses risk likelihood (likelihood or frequency of a fault) versus the criticality of requirement or effect of hazard to classify the risk into one of three categories (category 1, 2 or 3). This risk classification is then plotted against the probability of detection to determine high, medium and low priority of testing. A high-risk classification coupled with a low likelihood of detection determines the highest class of test priority. This probably encapsulates the overall approach of the guide in my view — regulatory rationale rather than business approach in contrast to the stated aims of the guide in the introduction. Using this approach, I believe that you will be performing over complex and over detailed risk assessments forever for commercial systems that constitute the majority of laboratory systems. What the writers of the GPG have forgotten is that the FDA has 7gone back to basics with Part 11 interpretation. Remember that the GMP predicate rules (21 CFR 211 and ICH Q7A for active pharmaceutical ingredients) for equipment/computerized systems state: ?211.63 Equipment Design, Size and Location: Equipment used in the manufacture, processing, packing or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning 8and maintenance. ICH Q7A (GMP for active pharmaceutical ingredients), in ?5.4 on Computerized Systems states in ?5.42: Commercially available software that has been qualified does not require 9the same level of testing. The fundamental aim of any computerized system validation should be to define its intended use and then test it to demonstrate that it complies with specification. The risk assessment should focus the testing effort where it is needed most but built on the testing 2that a vendor has already done as the GPG notes on page 34. Where a vendor has tested the system in the way that you use it (either in system testing or the OQ) then why do you need to repeat this? 28 附录2覆盖测试的优先级是一个相对较短的部分，需要每一个要求在你和评估风险的可能性(故障的可能性或频率)与危害的要求或影响临界将风险分为三个类别(1，2或3类)。这种风险分类然后暗算的检测概率确定的高，中，低优先级的测试。一个高风险的分类，再加上低似然检测确定优先级最高的类测试。 这可能是封装在我看来-导向监管的理由而不是相反的目的在介绍导游业务方法的总体方法。使用这种方法，我相信你会在复杂和详细的风险评估，永远的商业系统，构成了实验室系统多数表演。你的GPG作家已经被遗忘的是，FDA已回到11部分解释的基础知识。7记住，GMP谓词规则(21 CFR 211和ICH Q7A活性药物成分)设备/计算机系统的状态: ?211.63设备的设计，大小和位置:用于制造，加工设备，包装和保存药物应设计合理，大小适当，布置合理，便于操作，其使用、清洁和维护。8 ICH Q7A(GMP为药物活性成分)，在?5.4计算机系统状态?5.42:经证明合格的商用软件不需要相同程度的检测。9 任何计算机系统验证的根本目的应该是定义它的用途，然后进行测试，证明其符合规范。风险评估应该集中测试工作最需要的地方却建立在测试一 29 个供应商已经为GPG笔记34.2页，一个供应商所测试的系统在你使用它 (无论是在系统测试或OQ)那你为什么需要重复这个, Cavalry to the Rescue? — AAPS Guide on Instrument Qualification As usual in the world, each professional group MUST have their own say in how things should be done. The American Association of Pharmaceutical Scientists (AAPS) is no exception and has produced a white paper titled "Qualification of analytical instruments for 4use in the pharmaceutical industry; a scientific approach". Of course, this is a different approach from GAMP. However, on the bright side the dishwashers bit the dust long before the final version of this publication! In contrast to the GAMP GPG, which looks at laboratory equipment from the computer perspective, the AAPS document looks at the same issue from equipment qualification perspective. The AAPS white paper has devised three classes of instruments with a user requirements specification necessary to start the process. , Group A instruments: Conformance to the specification is achieved visually with no further qualification required. Examples of this group are ovens, vortex mixers, magnetic stirrers and nitrogen evaporators. , Group B instruments: Conformance to specification is achieved according to the individual instrument's SOP. Installation of the instrument is relatively simple and causes of failure can be easily observed. Examples of instruments in this group are balance, IR spectrometers, pipettes, vacuum ovens and thermometers. , Group C instruments: Conformance to user requirements is highly method specific according to the guide. Installation can be complex and require specialist skills (e.g., the vendor). A full qualification is required for the following spectrometers: atomic absorption, flame absorption, ICP, MS, Raman, UV/vis and XRF. OK this approach is simpler but the only consideration of the computer aspects is limited to data storage, back-up and archive. Thus, this approach is rather simplistic from the computer validation perspective. 30 骑兵的拯救,- AAPs仪器鉴定指南 像往常一样，在世界上，各专业组必须有自己说的事情应该怎么做。美国药学科学家协会(AAPS)也不例外，产生了一个白皮书，题为―应用于制药行业分析仪器资格;科学的方法‖。4，当然，这是一种不同的方法从多糖。然而，在光明的一面的洗碗机倒地之前很久，本出版物的最终版本～ 在对比了GAMP GPG，着眼于从计算机的角度的实验室设备，AAPs的文件从设备角度看资质相同的问题。AAPS白皮书已经设计了三类仪器与用户要求规范必要的启动过程。 •集团的工具:对规范的一致性是实现视觉上没有进一步的资格要求。这一组的例子是烤箱，旋涡混合器，磁力搅拌器和氮的蒸发器。 •B组仪器:符合规格是根据个人仪表的SOP实现。仪器的安装是比较简单和失败的原因，可以很容易地观察。本组仪器有平衡，红外光谱仪，移液管，真空烤箱温度计。 •C类仪器:用户要求的一致性是高度特定方法根据指南。安装非常复杂，需要专门的技能(例如，供应商)。一个完整的资格是下列要求:原 31 子吸收光谱仪，火焰原子吸收，ICP，MS，拉曼光谱，紫外/可见光和X 射线荧光。 这方法很简单，但在计算机方面唯一考虑的是有限的数据存储，备份和归 档。因此，这种方法是从计算机的角度而不是简单的验证。 Furthermore, the definition of IQ, OQ and PQ is from the equipment qualification perspective (naturally) with operational release occurring after the OQ stage and PQ intended to ensure continued performance of the instrument. This is different from the GAMP GPG, which uses the computer validation definition of IQ, OQ and PQ where PQ is 4end user testing and operational release occurs after the end of the PQ phase. This is a great problem when two major publications cannot agree on terminology for the same subject. However, the AAPS white paper is now the baseline document for the new proposed 3general chapter <1058> for the USP XXIX; the draft of which was published for comment 7in Pharmacopoeial Forum. This highlights the flawed approach of the GAMP GPG because there is now a de facto differentiation between laboratory equipment qualification and computer system validation that will be incorporated in the USP. So are we any further forward? Not really — we are just nibbling at the problem from a different perspective but without solving it decisively. Consider the following issues that are not fully covered by the AAPS guide that will now be enshrined in a formal regulatory text: , The scope of the guidance and proposed USP chapter is limited only to commercial off-the-shelf analytical instrumentation and equipment. , The three instrument groups are described along with suggested testing approaches to be conducted for each. However, in my view, there is not sufficient definition of the criteria for placing instruments in particular groups. , Group C instruments cover a wide spectrum of complexity and risk, and may have very diverse requirements. There is no specific allowance made within the approach 32 for custom developed applications such as macros commonly found when operating spectrometers. , The guide covers the initial qualification activities for analytical instruments but there is very little on the validation of the software that controls the instrument. There is little guidance on operational, maintenance and control activities following implementation such as access control, change control, configuration management and data back-up. How many spectrometers can you name that don't have computer-controlled equipment and data acquisition? , The proposed chapter uses the term "analytical instrument qualification" (AIQ) to describe the process of ensuring that an instrument is suitable for its intended application but the instrument is only a part of the whole computerized system. It is the computerized system that controls the whole — not the instrument. , ON划词翻译ON实时翻译 , 此外，智商的定义，OQ和PQ是从设备的资格的角度(自然)操 作释放后发生的OQ阶段和PQ为了保证仪器的持续性。这是由不 同的GAMP GPG，采用计算机验证定义IQ，OQ和PQ PQ是的 PQ阶段结束后的最终用户测试和操作的释放发生。4这是一个很大 的问题时，两个主要出版物不能同意对术语相同的主题。 , 然而，AAPs的白皮书现在是新提出的总章,1058,为美国药典29 基线文件;3的初稿在药典论坛发表评论。7这一集锦的GAMP GPG的有缺陷的方法，现在阿德事实上的分化实验设备和计算机系 统验证的资格将纳入USP。 33 , 所以我们任何进一步的了,不是真的-我们只是细咬着从不同的角度 的问题，但没有果断地解决它。考虑以下问题，没有完全覆盖的 AAPS向导现在将体现在一个正式的规范文本: , •的指导范围提出了USP章只限于商业现成的分析仪器和设备。 , •三仪器组的描述以及建议进行每个测试方法。然而，在我看来，没 有足够的标准定义放置仪器在特定群体。 , •C类仪器覆盖广泛的复杂性和风险，并可能有非常不同的要求。没 有具体的限额内的方法定制开发的应用如宏操作时常见的光谱仪。 , •导套的初始确认活动分析仪器，但对控制仪验证软件很小。很少有 指导操作，维护和控制实施后如访问控制，变更控制活动，配置管 理和数据备份。你能说出多少光谱仪没有电脑控制的设备和数据采 集, , •该章使用术语―仪器确认‖(AIQ)来描述的过程中，确保用于仪器 但仪器只是整个计算机系统的一部分。它是控制整个计算机系统不 仪。 34 Integrated Approach to Computer Validation AND Instrument Qualification What we really need for any regulated laboratory is an integrated approach to the twin problems of instrument qualification and computer validation. As noted by the GAMP GPG, the majority of laboratory and spectrometer systems come with some degree of 2computerization from firmware to configurable off-the-shelf software. The application software controls the instrument. If you qualify the instrument you will usually need the software to undertake many of the qualification tests with an option to validate the software at the time. BUT... we look at the two issues separately. 32Consider the AAPS Analytical Instrument Qualification guide and GAMP laboratory GPG as two examples that we have looked at in this column. They are looking at different parts of the same overall problem and coming up with two different approaches. No wonder if we don't take a considered and holistic view of the whole problem. For example, we use the same qualification terminology (IQ, OQ and PQ) for both 10instrument qualification and computer system validation but they mean different things. This fact is exemplified in the two guides. Confused? You should be. If you are not — then you have not understood the problem! 集成的方法和仪器的计算机验证资格 我们真的需要任意调节的实验室是一个集成的方法中存在的两个仪器和计 算机验证资格。根据GAMP GPG指出，实验室和光谱仪系统多数有一定 程度的电算化从固件配置现成的软件。2应用软件控制仪器。如果你有资 格的仪器通常你会需要的软件进行许多测试与选择验证软件的时候。 但…我们看了这两个问题分别。 35 考虑AAPS仪器确认guide3和GAMP实验室gpg2作为两个实例，我们 看着这个专栏。他们正在寻找的整体问题的不同部分，提出了两种不同的 方法。毫无疑问，如果我们不采取考虑整个问题的整体观。 例如，我们使用相同的资格的术语(IQ，OQ和PQ)对仪器的确认和计 算机系统验证却意味着不同的事情这一事实是体现在两个向导。困惑,你 应该。如果你不是，那你还没有理解问题～ Therefore, we need to develop the following guidance as a minimum: , Integrated terminology covering both the qualification of the instrument and validation of the software. This must ensure that the laboratory is not separated from the organization or creates a profession of Lablish interpreters. , Simple classification of laboratory equipment software — based on the existing GAMP software categories to be consistent with the rest of the organization. The laboratory is not a unique part of a facility anymore than production is. , Realistic life cycle(s) based on the further development of the simple SILC outlined in the GPG that reflect the different options that we face in the laboratory: from COTS to configurable COTS and where necessary customization of an application , Writing a specification or specifications to document both the instrument and the associated software functions. Figure 2 shows one approach to an integrated approach by considering the equipment operational requirements at both the modular and holistic levels and the software functions required; both of which are based on the way of working in a specific laboratory. The equipment qualification requirements for traceable reference standards can also be devised for input into 10the URS. , Use of a simple to use but effective risk assessment methodology that reflects the majority of instrument and systems are commercial. 36 , Integrated and practical approaches to combined equipment qualification and computer validation to test and demonstrate that the system does what it is intended to do. I can go on (and usually do) in more detail but the plain truth is that we don't have this holistic approach yet. 因此，我们需要制定以下指导为最小: •综合术语涵盖资格的软件工具和验证。这必须保证实验室不从组织分离 或创建一个lablish口译专业。 基于现有的GAMP软件类别是与其他组织的一致的实验室设备的软件•简 单分类。该实验室是不是一个独特的部分再比生产设施。 •现实的生命周期(S)的基础上的简单的ILC的GPG，反映我们在实验 室里所面临的不同 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 的进一步发展:从COTS COTS和定制配置必要 的应用 •书写规范或规范记录仪器和相关的软件功能。图2通过考虑设备的操作 要求在模块化的整体水平和软件功能需要显示的综合方法的一种方法;二 是基于在一个特定的实验室工作的方式。可追溯的标准设备的资格要求， 也可设计为输入urs.10 •使用使用简单而有效的风险评估方法，反映了仪器系统多数是商业。 37 •集成和实用的方法，结合设备的资格和计算机验证试验表明，系统做它 是什么做的。 我可以(通常)更详细的但事实是我们没有这种全面的方法，然而。 Summary Qualification of laboratory equipment and validation of computerized laboratory systems are going into two different directions that lack an integrated approach. We need to have an integrated approach that recognizes that we need a combined approach to qualifying the instrument through the controlling software that also needs to be validated at the same time. This approach must harmonize the use of terminology and definitions. Until we have this integrated approach there will be confusion in this area. 摘要 实验室设备和计算机实验室的系统验证资格进入两个不同的方向，缺乏一 个综合的方法。我们需要有一个综合的方法，认识到我们需要一个合格的 仪器相结合的方法，通过控制软件，还需要在同一时间验证。这种方法必 须协调使用的术语和定义。直到我们有这种综合方法，在这方面将有混 乱。 References 1. R.D. McDowall, LCGC Eur., 19(5), 274–282 (2006). 38 2. GAMP Forum Good Practice Guide — Laboratory Systems; International Society for Pharmaceutical Engineering: Tampa, Florida, USA (2005). 3. United States Pharmacopeia XXIX (2006). 4. S.K. Bansal et al. Qualification of Analytical Instruments for Use in the Pharmaceutical Industry: A Scientific Approach, American Association of Pharmaceutical Scientists (2004). 5. Good Automated Manufacturing Practice (GAMP) guidelines version 4, International Society of Pharmaceutical Engineering, Tampa, Florida, USA (2001). 6. R.D. McDowall, Quality Assurance Journal, 9, 196–227 (2005). 7. FDA Guidance for Industry on Part 11 Scope and Application (2003). 8. FDA Current Good Manufacturing Practice for Finished Pharmaceutical Products (21 CFR 211). 9. ICH Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients (2000). 10. Pharmacopoeal Forum, <1058> Analytical Equipment Qualification, January 2005. 39