PDA Technical Documents P DA B O O KS TO RE

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PDA Technical Reports

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Revised 2007
1 01001 43381
Qualification and Ongoing Control (Published 1980)

3 Validation of Dry Heat Processes Used for Depyrogenation and Sterilization Revised 2013 43506
(Published 1981)

4 Design Concepts For the Validation of a Water for Injection System (Retired) 1983 43209
5 Sterile Pharmaceutical Packaging: Compatibility and Stability (Retired) 1984 43210
7 Depyrogenation (Retired) 1985 43212
9 Review of Commercially Available Particulate Measurement Systems (Retired) 1988 43214
10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (Retired) 1988 43215
11 Sterilization of Parenterals by Gamma Radiation (Retired) 1988 43216
12 Siliconization of Parenteral Drug Packaging Components 1988 43217
13 Fundamentals of an Environmental Monitoring Program Revised 2014 43513
(Published 1990)

14 Validation of Column-Based Chromatography Processes for the Purification of Proteins Revised 2008 43220
(Published 1992)

15 Validation of Tangential Flow Filtration in Biopharmaceutical Applications Revised 2009 01015 43221
(Published 1992)

16 Effects of Gamma Irradiation on Elastomeric Closures (Retired) 1992 43222

17 Current Practices in the Validation of Aseptic Processing -- 1992 (Retired) 1993 43223
18 Validation of Computer-Related Systems (Retired) 1995 43224
19 Rapid/Automated ID Methods Survey (Retired) 1990 43225
20 Report on Survey of Current Industry Gowning Practices (Retired) 1990 41239
21 Bioburden Recovery Validation (Retired) 1990 41258
22 Process Simulation for Aseptically Filled Products Revised 2011 43226
(Published 1996)

23 Industry Survey on Current Sterile Filtration Practices (Retired) 1997 43227

24 Current Practices in the Validation of Aseptic Processing (Retired) 1997 43228
25 Blend Uniformity Analysis: Validation and In-Process Testing (Retired) 1997 43229
26 Sterilizing Filtration of Liquids Revised 2008 43230
(Published 1998)

27 Pharmaceutical Package Integrity 1998 43231

28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Revised 2006 43232
(Published 1998)

29 Points to Consider for Cleaning Validation Revised 2012 9 43501

(Published 1998)

Parametric Release of Pharmaceuticals and Medical Device Products Terminally Revised 2012
30 43234
Sterilized by Moist Heat (Published 1999)

31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems (Retired) 1999 43235
Auditing of Suppliers Providing Computer Products and Services for Regulated Revised 2004
32 43236
Pharmaceutical Operations (Retired) (Published 1999)

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Revised 2013
33 3 43510
Methods (Published 2000)

Design and Validation of Isolator Systems for the Manufacturing and Testing
34 2001 01034 43239
of Health Care Products
A Proposed Training Model for the Microbiological Function in the Pharmaceutical
35 2001 43240
Industry (Retired)

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36 Current Practices in the Validation of Aseptic Processing – 2001 (Retired) 2002 43241 61 Steam In Place 2013 43503
Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): 62 Recommended Practices for Manual Aseptic Processes 2013 43505
38 2006 43315
Chemistry, Manufacturing, and Controls Documentation 63 Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials 2013 43507
Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of 64 Active Temperature-Controlled Systems: Qualification Guidance 2013 43509
39 2021 43556
Temperature-Sensitive Medicinal Products through the Transportation Environment
65 Technology Transfer 2014 43514
40 Sterilization Filtration of Gases 2005 01040 43314
66 Application of Single-Use Systems in Pharmaceutical Manufacturing 2014 43515
41 Virus Filtration 2008 01041 43313
Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals,
42 Process Validation of Protein Manufacturing 2005 01042 43311 67 2014 43516
Medical Devices, and Cosmetics
Identification and Classification of Nonconformities in Molded and Tubular Glass 68 Risk-Based Approach for Prevention and Management of Drug Shortages 2014 43517
43 Containers for Pharmaceutical Manufacturing: Covering Ampoules, Bottles, Revised 2013 43508
(Published 2007)
Cartridges, Syringes and Vials 69 Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations 2015 43521
44 Quality Risk Management for Aseptic Processes 2008 01044 43410 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing
70 2015 43522
Facilities
45 Filtration of Liquids Using Cellulose-Based Depth Filters 2008 43422
71 Emerging Methods for Virus Detection 2015 43523
Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products
46 2009 01046 43485 Passive Thermal Protection Systems for Global Distribution: Qualification and
to the End User 72 2015 43524
Operational Guidance
47 Preparation of Virus Spikes Used for Virus Clearance Studies 2010 43486
73 Prefilled Syringe User Requirements for Biotechnology Applications 2015 43525
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification
48 2010 43487 74 Reprocessing of Biopharmaceuticals 2016 43526
and Maintenance
49 Points to Consider for Biotechnology Cleaning Validation 2010 43488 75 Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters 2016 43528
50 Alternative Methods for Mycoplasma Testing 2010 43489 Identification and Classification of Visible Nonconformities in Elastomeric
76 2016 43529
Components and Aluminum Seals for Parenteral Packaging
Biological Indicators for Gas and Vapor-Phase Decontamination Processes:
51 2010 43490 The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal
Specification, Manufacture, Control and Use 77 2017 43531
Technology
Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply
52 2011 43491 Quality Risk Management for the Design, Qualification, and Operation of
Chain 54-5 2017 43533
Manufacturing Systems
53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011 43492
78 Particulate Matter in Oral Dosage Forms 2017 43535
Implementation of Quality Risk Management For Pharmaceutical and Biotechnology
54 2012 43493 79 Particulate Matter Control in Difficult to Inspect Parenterals 2018 43536
Manufacturing Operations
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology 80 Data Integrity Management System for Pharmaceutical Laboratories 2018 43537
54-2 Manufacturing Operations Annex 1: Case Study Examples for Quality Risk 2013 43504
81 Cell-Based Therapy Control Strategy 2019 43538
Management in Packaging and Labeling
82 Low Endotoxin Recovery 2019 43539
Implementation of Quality Risk Management for Pharmaceutical and
54-3 Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing 2013 43511 Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and
83 2019 43541
of Pharmaceutical Drug Products Response
Implementation of Quality Risk Management for Pharmaceutical and 54-6 Formalized Risk Assessment for Excipients 2019 43542
54-4 Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing 2014 43518 84 Integrating Data Integrity Requirements into Manufacturing & Packing Operations 2020 43547
of Biotechnological Bulk Drug Substances
13-2 Fundamentals of an Environmental Monitoring Program Annex 1 2020 43549
Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints
55 2012 43494 Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug
and Odors in the Pharmaceutical and Consumer Healthcare Industries 60-3 2021 43551
Substances Manufacturing
Application of Phase-Appropriate Quality System and cGMP to the Development Revised 2016
56 43530 Enhanced Test Methods for Visible Particle Detection and Enumeration on
of Therapeutic Protein Drug Substance (API or Biological Active Substance) (Published 2012)
85 2021 43552
Elastomeric Closures and Glass Containers
57 Analytical Method Validation and Transfer for Biotechnology Products 2012 43497
Industry Challenges and Current Technologies for Pharmaceutical Package Integrity
86 2021 43553
57-2 Analytical Method Development and Qualification for Biotechnology Products 2015 43519 Testing
58 Risk Management for Temperature-Controlled Distribution 2012 43499 87 Current Best Practices for Pharmaceutical Glass Vial Handling and Processing 2021 43555
59 Utilization of Statistical Methods for Production Monitoring 2012 43500 88 Microbial Data Deviation Investigations in the Pharmaceutical Industry 2022 43557
60 Process Validation: A Lifecycle Approach 2013 43502
Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid
60-2 2017 43532
Dosage Forms

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PDA Points to Consider Paper PDA Surveys

Points to Consider for Aseptic Processing - PDA Journal of Pharmaceutical Science Risk Mitigation of Tribromoanisole (TBA)/Trichloroanisole (TCA) Taints and Odors:
2003 42148 2011 45000
and Technology: 2003 Supplement Volume 57 Issue 2 A Pharmaceutical Industry Benchmarking Survey
Points to Consider for Aseptic Processing: Part 1, January 2015 2015 43520 Business Case for Pharmaceutical Quality 2012 45001
Points to Consider for Aseptic Processing: Part 2, May 2016 2016 43527 Glass Quality: 2011 and 2012 Results and Comparison 2013 45002
Points to Consider for Aging Facilities 2017 43534 2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer
2014 45003
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Health, Medical Devices, Dietary Supplement and Cosmetic Products
2020 43543
Isolators 2014 PDA Process Validation Survey 2014 45004
Points to Consider for Sensitivity to Oxidation by Peroxide 2020 43544 2014 Quality Culture Metrics 2015 45005
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration 2020 43545 2014 Visual Inspection 2015 45006
Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing 2020 43546 2015 Particulate Matter in Oral Dosage Forms 2016 45007
Points to Consider in Remote and Hybrid GMP/GDP Inspections 2021 43554 2015 Particulate Matter in Difficult to Inspect Parenterals 2016 45008
2015 Aging Facilities 2016 45009
2017 PDA Aseptic Processing Survey 2017 45010
2017 PDA PUPSIT Survey 2017 45011
2017 PDA Glass Quality Survey 2018 45012
2019 Technology Transfer Industry Survey 2019 45013
2019 Sterile Lyophilized Drug Product Loading Survey 2019 45014
2019 PDA Traceability of Primary Packaging Survey 2020 45015
2021 Post-Approval Change Issues and Impacts Survey 2021 45016
2020 Particulate Matter in Flexible Containers Survey 2021 45017

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