PDA_Technical_Reports_list

5/23/2012 1 PDA TECHNICAL REPORTS TITLE DATE OF PUBLICATION Paper Version Digital Version 01001 43381 1 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control 1980 (Revised 2007) 01003 43208 3 Validation of Dry Heat Processes Used for Sterilization and Depyrogenation 1981 01004 43209 4 Design Concepts for the Validation of Water-for-Injection Systems 1983 01005 43210 5 Sterile Pharmaceutical Packaging: Compatibility and Stability 1984 01007 43212 7 Depyrogenation 1985 01009 43214 9 Review of Commercially Available Particulate Measurement Systems 1988 01010 43215 10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers 1988 01011 43216 11 Sterilization of Parenterals by Gamma Radiation 1988 01012 43217 12 Siliconization of Parenteral Drug Packaging Components 1988 43218 13 Fundamentals of an Environmental Monitoring Program 1990 (Revised 2001) 01014 43220 14 Validation of Column-Based Chromatography Processes for the Purification of Proteins 1992 (Revised 2008) 01015 43221 15 Validation of Tangential Flow Filtration in Biopharmaceutical Applications 1992 (Revised 2009) 01016 43222 16 Effect of Gamma Irradiation on Elastomeric Closures 1992 01017 43223 17 Current Practices in the Validation of Aseptic Processing -- 1992 1993 01018 43224 18 Report on the Validation of Computer-Related Systems 1995 01019 43225 19 Rapid/Automated ID Methods Survey 1990 01020 41239 20 Report on Survey of Current Industry Gowning Practices 1990 01021 41258 21 Bioburden Recovery Validation 1990 43226 22 Process Simulation Testing for Aseptically Filled Products 1996 (Revised 2011) 43227 23 Industry Survey on Current Sterile Filtration Practices 1996 TECHNICAL REPORT 5/23/2012 2 TITLE DATE OF PUBLICATION Paper Version Digital Version TECHNICAL REPORT 01024 43228 24 Current Practices in the Validation of Aseptic Processing -- 1996 1996 43229 25 Blend Uniformity Analysis: Validation and In-Process Testing 1997 43230 26 Sterilizing Filtration of Liquids 1998 (Revised 2008) 43231 27 Pharmaceutical Package Integrity 1998 01028 43232 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals 1998 (Revised 2006) 43233 29 Points to Consider for Cleaning Validation 1998 01030 43234 30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat 1999 (Revised 2012) 01031 43235 31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems 1999 01032 43236 32 Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations 1999 (Revised 2004) 01033 43238 33 Evaluation, Validation and Implementation of New Microbiogical Testing Methods 2000 01034 43239 34 Design and Validation of Isolate Systems for the Manufacturing and Testing of Health Care Products 2001 01035 43240 35 A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry 2001 01036 43241 36 Current Practices in the Validation of Aseptic Processing -- 2001 2002 01038 43315 38 Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC): Chemistry, Manufacturing and Controls Documentation 2006 01039 43312 39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment 2007 01040 43314 40 Sterilization Filtration of Gases 2005 01041 43313 41 Virus Filtration 2008 01042 43311 42 Process Validation of Protein Manufacturing 2005 01043 43396 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing 2007 01044 43410 44 Quality Risk Management for Aseptic Processes 2008 01045 43422 45 Filtration of Liquids Using Cellulose-Based Depth Filters 2008 5/23/2012 3 TITLE DATE OF PUBLICATION Paper Version Digital Version TECHNICAL REPORT 01046 43485 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User 2009 43486 47 Preparation of Virus Spikes Used for Virus Clearance Studies 2010 43487 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance 2010 43488 49 Points to Consider for Biotechnology Cleaning Validation 2010 43489 50 Alternative Methods for Mycoplasma Testing 2010 43490 51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use 2010 43491 52 Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain 2011 43492 53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011 43493 54 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations 2012 43494 55 Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries 2012 Sheet1