PDA Technical Documents PDA BOOKSTORE

1 1 PDA Technical VersionDigital Version PDA Technical Reports1 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing ControlRevised 2007 (Published 1980)01001433813 Validation of Dry Heat Processes Used for depyrogenation and SterilizationRevised 2013 (Published 1981)435064 Design Concepts For the Validation of a Water for Injection System (Retired)1983432095 Sterile Pharmaceutical Packaging: Compatibility and Stability (Retired)1984432107 depyrogenation (Retired)1985432129 Review of Commercially Available Particulate Measurement Systems (Retired)19884321410 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (Retired)19884321511 Sterilization of Parenterals by Gamma Radiation (Retired)19884321612 Siliconization of Parenteral Drug Packaging Components19884321713 Fundamentals of an Environmental Monitoring ProgramRevised 2014 (Published 1990)4351314 Validation of Column-Based Chromatography Processes for the Purification of ProteinsRevised 2008 (Published 1992)4322015 Validation of Tangential Flow Filtration in Biopharmaceutical ApplicationsRevised 2009 (Published 1992)010154322116 Effects of Gamma Irradiation on Elastomeric Closures (Retired)19924322217 Current Practices in the Validation of Aseptic Processing -- 1992 (Retired)19934322318 Validation of Computer-Related Systems (Retired)19954322419 Rapid/Automated ID Methods Survey (Retired)19904322520 Report on Survey of Current Industry Gowning Practices (Retired)19904123921 Bioburden Recovery Validation (Retired)

2 19904125822 Process Simulation for Aseptically Filled ProductsRevised 2011 (Published 1996)4322623 Industry Survey on Current Sterile Filtration Practices (Retired)19974322724 Current Practices in the Validation of Aseptic Processing (Retired)19974322825 Blend Uniformity Analysis: Validation and In-Process Testing (Retired)19974322926 Sterilizing Filtration of LiquidsRevised 2008 (Published 1998)4323027 Pharmaceutical Package Integrity19984323128 Process Simulation Testing for Sterile Bulk Pharmaceutical ChemicalsRevised 2006 (Published 1998)4323229 Points to Consider for Cleaning ValidationRevised 2012 (Published 1998)94350130 Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist HeatRevised 2012 (Published 1999)4323431 Validation and Qualification of Computerized Laboratory Data Acquisition Systems (Retired)19994323532 Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (Retired)Revised 2004 (Published 1999)4323633 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological MethodsRevised 2013 (Published 2000)

3 34351034 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products2001010344323935A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry (Retired)2001432401/5 PDA 3 TITLEP aper VersionDigital Version36 Current Practices in the Validation of Aseptic Processing 2001 (Retired)20024324138 Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing, and Controls Documentation20064331539 Guidance for Temperature-Controlled Medicinal Products Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment20214355640 Sterilization Filtration of Gases2005010404331441 Virus Filtration2008010414331342 Process Validation of Protein Manufacturing2005010424331143 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampoules, Bottles, Cartridges, Syringes and VialsRevised 2013 (Published 2007)4350844 Quality Risk Management for Aseptic Processes2008010444341045 Filtration of Liquids Using Cellulose-Based Depth Filters20084342246 Last Mile.

4 Guidance for Good Distribution Practices for Pharmaceutical Products to the End User2009010464348547 Preparation of Virus Spikes Used for Virus Clearance Studies 20104348648 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance 20104348749 Points to Consider for Biotechnology Cleaning Validation20104348850 Alternative Methods for Mycoplasma Testing20104348951 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use 20104349052 Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain20114349153 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 20114349254 Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing Operations20124349354-2 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling20134350454-3 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products20134351154-4 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 3.

5 Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances20144351855 Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries20124349456 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)Revised 2016(Published 2012)4353057 Analytical Method Validation and Transfer for Biotechnology Products 20124349757-2 Analytical Method Development and Qualification for Biotechnology Products20154351958 Risk Management for Temperature-Controlled Distribution 20124349959 Utilization of Statistical Methods for Production Monitoring20124350060 Process Validation: A Lifecycle Approach20134350260-2 Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid Dosage Forms2017435322 VersionDigital Version61 Steam In Place20134350362 Recommended Practices for Manual Aseptic Processes20134350563 Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials20134350764 Active Temperature-Controlled Systems: Qualification Guidance20134350965 Technology Transfer 20144351466 Application of Single-Use Systems in Pharmaceutical Manufacturing20144351567 Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics20144351668 Risk-Based Approach for Prevention and Management of Drug Shortages20144351769 Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations20154352170 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities20154352271 Emerging Methods for Virus Detection20154352372 Passive Thermal Protection Systems for Global Distribution.

6 Qualification and Operational Guidance20154352473 Prefilled Syringe User Requirements for Biotechnology Applications20154352574 Reprocessing of Biopharmaceuticals20164352675 Consensus Method for Rating m Mycoplasma Reduction Filters20164352876 Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging20164352977 The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology20174353154-5 Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems20174353378 Particulate Matter in Oral Dosage Forms20174353579 Particulate Matter Control in Difficult to Inspect Parenterals20184353680 Data Integrity Management System for Pharmaceutical Laboratories20184353781 Cell-Based Therapy Control Strategy20194353882 Low Endotoxin Recovery20194353983 Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response20194354154-6 Formalized Risk Assessment for Excipients20194354284 Integrating Data Integrity Requirements into Manufacturing & Packing Operations20204354713-2 Fundamentals of an Environmental Monitoring Program Annex 120204354960-3 Process Validation: A Lifecycle Approach Annex 2.

7 Biopharmaceutical Drug Substances Manufacturing20214355185 Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers20214355286 Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing20214355387 Current Best Practices for Pharmaceutical Glass Vial Handling and Processing20214355588 Microbial Data Deviation Investigations in the Pharmaceutical Industry202243557 3 5 TITLEP aper VersionDigital VersionPDA Points to Consider PaperPoints to Consider for Aseptic Processing - PDA Journal of Pharmaceutical Science and Technology: 2003 Supplement Volume 57 Issue 2 200342148 Points to Consider for Aseptic Processing: Part 1, January 2015201543520 Points to Consider for Aseptic Processing: Part 2, May 2016 201643527 Points to Consider for Aging Facilities 201743534 Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators202043543 Points to Consider for Sensitivity to Oxidation by Peroxide202043544 Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration202043545 Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing202043546 Points to Consider in Remote and Hybrid GMP/GDP Inspections2021435544 VersionDigital VersionPDA SurveysRisk Mitigation of Tribromoanisole (TBA)/Trichloroanisole (TCA) Taints and Odors.

8 A Pharmaceutical Industry Benchmarking Survey201145000 Business Case for Pharmaceutical Quality201245001 Glass Quality: 2011 and 2012 Results and Comparison2013450022013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products 2014450032014 PDA Process Validation Survey2014450042014 Quality Culture Metrics2015450052014 Visual Inspection2015450062015 Particulate Matter in Oral Dosage Forms2016450072015 Particulate Matter in Difficult to Inspect Parenterals2016450082015 Aging Facilities2016450092017 PDA Aseptic Processing Survey2017450102017 PDA PUPSIT Survey2017450112017 PDA Glass Quality Survey2018450122019 Technology Transfer Industry Survey2019450132019 Sterile Lyophilized Drug Product Loading Survey2019450142019 PDA Traceability of Primary Packaging Survey2020450152021 Post-Approval Change Issues and Impacts Survey2021450162020 Particulate Matter in Flexible Containers Survey2021450175