PDA Technical Reports PDA BOOKSTORE

Paper Digital
No. TITLE Version Version
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 01003 43506
(Published 1981)

4 Design Concepts for the Validation of Water-for-Injection Systems 1983 01004 43209
5 Sterile Pharmaceutical Packaging: Compatibility and Stability 1984 01005 43210
7 Depyrogenation 1985 01007 43212
9 Review of Commercially Available Particulate Measurement Systems 1988 01009 43214
10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers 1988 01010 43215
11 Sterilization of Parenterals by Gamma Radiation 1988 01011 43216
12 Siliconization of Parenteral Drug Packaging Components 1988 01012 43217
13 Fundamentals of an Environmental Monitoring Program Revised 2014 01013 43513
(Published 1990)

14 Validation of Column-Based Chromatography Processes for the Purification of Proteins Revised 2008 01014 43220
(Published 1992)

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

16 Effect of Gamma Irradiation on Elastomeric Closures 1992 01016 43222

17 Current Practices in the Validation of Aseptic Processing -- 1992 1993 01017 43223
18 Report on the Validation of Computer-Related Systems 1995 01018 43224
19 Rapid/Automated ID Methods Survey 1990 01019 43225
20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239
21 Bioburden Recovery Validation 1990 01021 41258
22 Process Simulation for Aseptically Filled Products Revised 2011 43226
(Published 1996)

23 Industry Survey on Current Sterile Filtration Practices 1996 43227

24 Current Practices in the Validation of Aseptic Processing – 1996 1996 01024 43228
25 Blend Uniformity Analysis: Validation and In-Process Testing 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 01028 43232
(Published 1998)

29 Points to Consider for Cleaning Validation Revised 2012 01029 43501

(Published 1998)

Parametric Release of Pharmaceuticals and Medical Device Products Terminally Revised 2012
30 01030 43234
Sterilized by Moist Heat (Published 1999)

31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems 1999 01031 43235
Auditing of Suppliers Providing Computer Products and Services for Regulated Revised 2004
32 01032 43236
Pharmaceutical Operations (Published 1999)

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Revised 2013
33 01033 43510
Methods (Published 2000)

Design and Validation of Isolate 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 01035 43240
Industry

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 Paper Digital Paper Digital
TITLE Version Version TITLE Version Version
36 Current Practices in the Validation of Aseptic Processing – 2001 2002 01036 43241 63 Quality Requirements for the Extemporaneous Preparation of Clinical Trial 2013 01063 43507
Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC): 64 Active Temperature-Controlled Systems: Qualification Guidance 2013 01064 43509
38 2006 01038 43315
Chemistry, Manufacturing and Controls Documentation 65 Technology Transfer 2014 01065 43514
Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of
39 2007 01039 43312 66 Application of Single-Use Systems in Pharmaceutical Manufacturing 2014 01066 43515
Temperature-Sensitive Medicinal Products through the Transportation Environment
Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals,
40 Sterilization Filtration of Gases 2005 01040 43314 67 2014 01067 43516
Medical Devices, and Cosmetics
41 Virus Filtration 2008 01041 43313
68 Risk-Based Approach for Prevention and Management of Drug Shortages 2014 43517
42 Process Validation of Protein Manufacturing 2005 01042 43311
Points to Consider for Aseptic Processing: Part 1, January 2015 2015 03005 43520
Identification and Classification of Nonconformities in Molded and Tubular Glass Revised 2013
43 01043 43508 69 Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations 2015 01069 43521
Containers for Pharmaceutical Manufacturing (Published 2007)

44 Quality Risk Management for Aseptic Processes 2008 01044 43410

45 Filtration of Liquids Using Cellulose-Based Depth Filters 2008 01045 43422
Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products
46 2009 01046 43485
to the End User
47 Preparation of Virus Spikes Used for Virus Clearance Studies 2010 01047 43486
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification
48 2010 01048 43487
and Maintenance
49 Points to Consider for Biotechnology Cleaning Validation 2010 01049 43488

PMS CMYK RGB

50 Alternative Methods for Mycoplasma Testing 2010 01050 43489
Biological Indicators for Gas and Vapor-Phase Decontamination Processes:
51 2010 01051 43490
Specification, Manufacture, Control and Use
52 Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain 2011 01052 43491

301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155

53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011 01053 43492
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology
54 2012 01054 43493
Manufacturing Operations
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology
54-2 Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk 2013 01054.2 43504
Management in Packaging and Labeling
Implementation of Quality Risk Management for Pharmaceutical and
54-3 Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing 2013 01054-3 43511
of Pharmaceutical Drug Products
Implementation of Quality Risk Management for Pharmaceutical and
54-4 Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing 2015 01054-4 43518
of Biotechnological Bulk Drug Substances
Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints
55 2012 01055 43494
and Odors in the Pharmaceutical and Consumer Healthcare Industries
Application of Phase-Appropriate Quality Systems and CGMP to the Development
56 2012 01056 43496
of Therapeutic Protein Drug Substance
57 Analytical Method Validation and Transfer for Biotechnology Products 2012 01057 43497
57-2 Analytical Method Development and Qualification for Biotechnology Products 2014 01057-2 43519
58 Risk Management for Temperature-Controlled Distribution 2012 01058 43499
59 Utilization of Statistical Methods for Production Monitoring 2012 01059 43500
60 Process Validation: A Lifecycle Approach 2013 01060 43502
61 Steam In Place 2013 01061 43503
62 Recommended Practices for Manual Aseptic Processes 2013 01062 43505

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