PDA Technical Reports

Paper
Version

Digital
Version

Revised 2007

01001

43381

Revised 2013
(Published 1981)

01003

43506

Design Concepts for the Validation of Water-for-Injection Systems

1983

01004

43209

Depyrogenation

1985

01007

43212

No.

TITLE

Validation of Moist Heat Sterilization Processes: Cycle Design, Development,

Qualification and Ongoing Control

Validation of Dry Heat Processes Used for Depyrogenation and Sterilization

4
5
7
9
10
11
12

PDA BOOKSTORE

Sterile Pharmaceutical Packaging: Compatibility and Stability

(Published 1980)

1984

Review of Commercially Available Particulate Measurement Systems

Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers

Sterilization of Parenterals by Gamma Radiation

Siliconization of Parenteral Drug Packaging Components

1988
1988
1988
1988

01005
01009
01010
01011
01012

43210
43214
43215
43216
43217

13

Fundamentals of an Environmental Monitoring Program

Revised 2014

01013

43513

14

Validation of Column-Based Chromatography Processes for the Purification of Proteins

Revised 2008

01014

43220

15

Validation of Tangential Flow Filtration in Biopharmaceutical Applications

Revised 2009
(Published 1992)

01015

43221

16

Effect of Gamma Irradiation on Elastomeric Closures

1992

01016

43222

Report on the Validation of Computer-Related Systems

1995

01018

43224

17
18
19
20
21

Current Practices in the Validation of Aseptic Processing -- 1992

1990

Bioburden Recovery Validation

23

Industry Survey on Current Sterile Filtration Practices

25

1990

Report on Survey of Current Industry Gowning Practices

Process Simulation for Aseptically Filled Products

1990

Current Practices in the Validation of Aseptic Processing 1996

Sterilizing Filtration of Liquids

27

Pharmaceutical Package Integrity

01017
01019
01020
01021

43223
43225
41239
41258

Revised 2011
(Published 1996)

43226

1996

43227

1996

Blend Uniformity Analysis: Validation and In-Process Testing

26

(Published 1992)

1993

Rapid/Automated ID Methods Survey

22
24

(Published 1990)

1997

01024

43228
43229

Revised 2008
(Published 1998)

43230

1998

43231

28

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

Revised 2006

29

Points to Consider for Cleaning Validation

Revised 2012

01029

43501

30

Parametric Release of Pharmaceuticals and Medical Device Products Terminally

Sterilized by Moist Heat

Revised 2012
(Published 1999)

01030

43234

Auditing of Suppliers Providing Computer Products and Services for Regulated

Pharmaceutical Operations

1999

01031

43235

Revised 2004

01032

43236

Revised 2013
(Published 2000)

01033

43510

2001

01034

43239

2001

01035

43240

31
32
33
34
35

(Published 1998)
(Published 1998)

Validation and Qualification of Computerized Laboratory Data Acquisition Systems

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological

Methods
Design and Validation of Isolate Systems for the Manufacturing and Testing
of Health Care Products

A Proposed Training Model for the Microbiological Function in the Pharmaceutical

Industry

(Published 1999)

www.pda.org/bookstore

01028

43232

Paper
Version

Digital
Version

2002

01036

43241

2006

01038

43315

Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of

Temperature-Sensitive Medicinal Products through the Transportation Environment

2007

01039

43312

66

Sterilization Filtration of Gases

43314

Process Validation of Protein Manufacturing

2008

01040

67

Virus Filtration

2005
2005

01042

43311

TITLE
36
38
39
40
41
42

Current Practices in the Validation of Aseptic Processing 2001

Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC):

Chemistry, Manufacturing and Controls Documentation

Identification and Classification of Nonconformities in Molded and Tubular Glass

Containers for Pharmaceutical Manufacturing

01041

43313

Revised 2013
(Published 2007)

01043

43508

Quality Risk Management for Aseptic Processes

2008

01044

43410

Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products
to the End User

2009

01046

43485

2010

01047

43486

2010

01048

43487

2010

01049

43488

2010

01051

43490

2011

01052

43491

2012

01054

43493

2013

01054.2

43504

2013

01054-3

43511

2015

01054-4

43518

2012

01055

43494

2012

01056

43496

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

Risk Management for Temperature-Controlled Distribution

2012

01058

43499

Process Validation: A Lifecycle Approach

2013

01060

43502

43
44
45
46
47
48
49
50
51
52
53
54

Filtration of Liquids Using Cellulose-Based Depth Filters

2008

Preparation of Virus Spikes Used for Virus Clearance Studies

Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification

and Maintenance
Points to Consider for Biotechnology Cleaning Validation

PMS

Alternative Methods for Mycoplasma Testing

Biological Indicators for Gas and Vapor-Phase Decontamination Processes:

Specification, Manufacture, Control and Use

Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain

301

Guidance for Industry: Stability Testing to Support Distribution of New Drug Products

CMYK
2010

Implementation of Quality Risk Management for Pharmaceutical and

54-3 Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing

of Pharmaceutical Drug Products

Implementation of Quality Risk Management for Pharmaceutical and

54-4 Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing

of Biotechnological Bulk Drug Substances

56
57
58
59
60
61
62

Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints

and Odors in the Pharmaceutical and Consumer Healthcare Industries
Application of Phase-Appropriate Quality Systems and CGMP to the Development
of Therapeutic Protein Drug Substance

Utilization of Statistical Methods for Production Monitoring

Steam In Place

Recommended Practices for Manual Aseptic Processes

01050

63
64
65

68
69

2011

2012
2013
2013

01053

01059
01061
01062

www.pda.org/bookstore

Paper
Version

Digital
Version

Quality Requirements for the Extemporaneous Preparation of Clinical Trial

2013

01063

43507

Technology Transfer

2014

01065

43514

Active Temperature-Controlled Systems: Qualification Guidance

Application of Single-Use Systems in Pharmaceutical Manufacturing

Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals,

Medical Devices, and Cosmetics

2013
2014
2014

Risk-Based Approach for Prevention and Management of Drug Shortages

2014

Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

2015

Points to Consider for Aseptic Processing: Part 1, January 2015

2015

01064
01066
01067
03005
01069

43509
43515
43516
43517
43520
43521

43422

RGB

43489

C:100 M:45 Y:0 K:18

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology

Manufacturing Operations

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology

54-2 Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk
Management in Packaging and Labeling

55

01045

TITLE

43492

43500
43503
43505

R:51 G:95 B:155