PDA BOOKSTORE

LEADING BIO/PHARMACEUTICAL
PUBLICATIONS AND RESOURCES
FOR YOUR PROFESSIONAL LIBRARY
CONTAMINATION
CONTROL IN
HEALTHCARE
PRODUCT
MANUFACTURING
Volume 2

Russell E. Madsen and Jeanne Moldenhauer

Editors

For more information or to purchase, please visit

www.pda.org/bookstore
 Connecting People, Science and Regulation®

Table of DEAR CUSTOMER,

Contents The Parenteral Drug Association (PDA) Bookstore is home

to over 894 publications, offered in both traditional and
online formats.
PDA TECHNICAL
BOOKS An extensive array of bio/pharmaceutical publications and
Pages 3-8
technical guides that provide you with the latest scientific
PDA TECHNICAL and regulatory information in our industry. These include
REPORTS our Technical Books, which are developed specifically
Pages 9-13 for the needs of pharmaceutical and biopharmaceutical
professionals, and our PDA Technical Reports that are peer-
TECHNICAL REPORT
reviewed documents written by subject matter experts.
PORTAL
Page 9 We invite you to explore our inventory of recently and
forthcoming publications online (www.pda.org/bookstore)
PROCEEDINGS
AND SURVEYS and in this brochure.
Page 14
We are proud to offer you these quality resources.
HOW TO ORDER Sincerely,
Page 14 Richard Johnson
President, PDA
THE PDA JOURNAL
Page 15

About PDA
The Parenteral Drug Association (PDA) is the leading
global provider of science, technology and regulatory
information and education for the pharmaceutical and
biopharmaceutical community. Founded in 1946 as a
nonprofit organization, PDA is committed to developing
scientifically sound, practical technical information and
resources to advance science and regulation through the
expertise of its nearly 10,000 members worldwide.
To learn more about our community, please visit
www.pda.org.

2 www.pda.org/bookstore
 PDA BOOKSTORE

PDA Technical Books

PDA Technical Books are scientific and regulatory books specifically developed for the professional
needs of pharmaceutical and biopharmaceutical professional. Written by expert industry leaders in
their field and peer reviewed, each serves as a practical guide and reference for specific topics facing
practitioners in the pharmaceutical and allied industries.

For a complete list of PDA Technical Books, please visit www.pda.org/bookstore

ANATOMY OF A
Upcoming Releases PHARMACEUTICAL FILTRATION:
DIFFERENTIAL PRESSURES,
CONTAMINATION CONTROL IN FLOW RATES, FILTER AREAS,
CONTAMINATION
CONTROL IN
HEALTHCARE PRODUCT THROUGHPUTS AND
HEALTHCARE MANUFACTURING, VOLUME 2 FILTER SIZING
PRODUCT Editors: Russell E. Madsen Authors: Maik Jornitz and
MANUFACTURING
Volume 2
and Jeanne Moldenhauer Theodore Meltzer
Item No. 17317
This book is the eighth volume
Russell E. Madsen and Jeanne Moldenhauer on the subject of various aspects of pharmaceutical
Editors

filtration collaboratively written by these authors.

2009. Hardcover 406 pages. Item No. 17261
THE FMEA HANDBOOK: Member: $250 / Nonmember: $309 / Government: $210
THE FMEA RISK MANAGEMENT TOOLS,
HANDBOOK
VOLUME 1
RISK MANAGEMENT
TOOLS
Author: Mike Long THE BACTERIAL ENDOTOXINS
Volume 1
Item No. 17319 TEST: A PRACTICAL GUIDE
Editor: Karen McCullough
TECHNOLOGY AND KNOWLEDGE TRANSFER
KEYS TO SUCCESSFUL IMPLEMENTATION AND MANAGEMENT
Mike Long
This unique book is a collection
of interdependent chapters that
are part lab manual, part essay,
TECHNOLOGY AND part historical context, part
TECHNOLOGY consultant and part plain sage
AND KNOWLEDGE
KNOWLEDGE TRANSFER: KEYS
TRANSFER TO SUCCESSFUL advice that provide a practical
and compliant approach to the execution and use of
KEYS TO SUCCESSFUL IMPLEMENTATION AND
IMPLEMENTATION AND bacterial endotoxins test. 2011. Hardcover. 434 pages.
MANAGEMENT MANAGEMENT
Item No. 17297
Editors: Mark Gibson and
Siegfried Schmitt Member: $210 / Nonmember: $259 / Government: $165
Mark Gibson and Siegfried Schmitt
Editors Item No. 17318

www.pda.org/bookstore 3
 Connecting People, Science and Regulation®
BIOFILM CONTROL IN DRUG
MANUFACTURING
Editors: Lucia Clontz and
Carmen Wagner
This book provides guidance
in preventing and controlling
biofilm contamination
in pharmaceutical and
biopharmaceutical processing.
2012. Hardcover. 496 pages. Item No. 17306
Member: $240 / Nonmember: $299 / Government: $190
CLEANING AND
NEW
CLEANING VALIDATION,
VOLUME 2
Editor: Paul L. Pluta
“Cleaning and Cleaning
Validation” is a series of
volumes containing current
knowledge and approaches
to cleaning and cleaning
validation of pharmaceuticals,
medical devices, and associated products. Volume
two, “Application of Basics and Principles,” builds on
the foundation of concepts provided in volume one.
Twenty-five chapters address the lifecycle approach
to cleaning validation; discussion of specific process
residues and their cleaning; equipment, including
equipment to be cleaned and cleaning equipment; and,
much more! 2013. Hardcover. 592 pages. Item No. 17298
Member: $335 / Nonmember: $419 / Government: $290
Bundle of Volume 1 & 2
Save 20% when you buy the two volume set!
Item No. 17309
Member: $535 / Nonmember: $670 / Government: $465
4 www.pda.org/bookstore
CLEANING VALIDATION:
NEW
PRACTICAL COMPLIANCE
SOLUTIONS FOR PHARMACEUTICAL
MANUFACTURING, VOLUME 3
Author: Destin LeBlanc
Volume 3, a complement to
Destin’s two earlier books on
the same subject, presents
modifications and updates of
his monthly Cleaning Memos originally published from
January 2009 through December 2012. Each Cleaning
Memo is presented as a chapter, with the chapters
then organized by common topics. For example, topics
related to setting limits are in one section, those
related to sampling in another section, and so forth. An
appendix with a list of acronyms is included as well.
2013. Hardcover. 248 pages. Item No. 17310
Member: $265 / Nonmember: $329 / Government: $180
Bundle of Volume 1, 2 & 3
Save 20% when you buy the three volume set!
Item No. 17312
Member: $635 / Nonmember: $790 / Government: $435
COMBINATION
NEW
COMBINATION PRODUCTS:
PRODUCTS
IMPLEMENTATION OF CGMP
IMPLEMENTATION
OF cGMP REQUIREMENTS
REQUIREMENTS
Editor: Lisa A. Hornback
The goal of this book is to
Lisa A. Hornback provide the reader with a well-
Editor
rounded exposure to the unique
aspects and considerations
for implementation of cGMP in a combination product
environment and also includes information from leaders
in the industry regarding the unique requirements for
several common combination products situations.
2013. Hardcover. 200 pages.
Print version: Item No. 17313
Digital version: Item No. 17951
Member: $210 / Nonmember: $259 / Government: $170
 PDA BOOKSTORE

CONTAMINATION
CONTAMINATION NEW
CONTROL IN
CONTROL IN
HEALTHCARE HEALTHCARE PRODUCT
PRODUCT
MANUFACTURING
MANUFACTURING, VOLUME 1
Volume 1
Editors: Russell Madsen and
Jeanne Moldenhauer

In this first book of the

Russell E. Madsen and Jeanne Moldenhauer
Editors

contamination control
series, you will be provided
with a wealth of information that can aid you in
understanding the sources of contamination, types
of control measures that can be used, methods
to use when contamination occurs and regulatory
expectations for management of these systems.
2013. 524 pages. Hardcover.
Print version: Item No. 17311
Digital version: Item No. 17952
ENVIRONMENTAL MONITORING: A COMPREHENSIVE
Member: $240 / Nonmember: $299 / Government: $210
HANDBOOK, VOLUME I, II, III, IV, V, VI AND
PROTOCOL CD
ENCYCLOPEDIA Editor: Jeanne Moldenhauer
NEW
OF RAPID These six volumes, with 112 chapters written by
MICROBIOLOGICAL METHODS, subject matter experts worldwide, describe methods for
VOLUME 4 developing and operating an appropriate, sustainable
Editor: Michael Miller microbiological program for production and the
laboratory. Each volume is different insofar as each
Pharmaceutical microbiologists
speaks about different environmental monitoring
would be well served by
issues. Numerous useful protocols are included on CD.
considering which of their
2012. Hardcover. Item No. 17305
samples would provide a
benefit with a more rapid result and then assessing Member: $1,630 / Nonmember: $2,030 /
the current alternate microbiological methods to see Government: $1,190
if any of them are a good fit for their needs. The
Available for Individual Purchase:
Encyclopedia of Rapid Method would be an excellent
resource to start that assessment. 2013. Hardcover.
Volume I 2005. Hardcover 455 pages. (Item No. 17211)
608 pages. Item No. 17308
Volume II 2005. Hardcover 459 pages. (Item No. 17237)
Member: $335 / Nonmember: $419 / Government: $290 Volume III 2009. Hardcover 312 pages. (Item No. 17285)
Volume IV 2010. Hardcover 234 pages. (Item No. 17291)
Volume V 2011. Hardcover 234 pages. (Item No. 17299)
Volume VI 2012. Hardcover 333 pages. (Item No. 17304)

Each Volume:
Member: $335 / Nonmember: $419 / Government: $290

Protocol CD
2005. 781 pages. Item No. 17238
Member: $75 / Nonmember: $89 / Government: $45

www.pda.org/bookstore 5
 Connecting People, Science and Regulation®
GMP IN PRACTICE:
REGULATORY EXPECTATIONS
FOR THE PHARMACEUTICAL
INDUSTRY, FOURTH EDITION,
REVISED & EXPANDED
Author: James Vesper
In order to get a rich
understanding of GMP, a person
needs to have knowledge of
what various national authorities expect. This book
is designed to help you achieve this goal. 2011.
Hardcover. 618 pages. Item No. 17269
Member: $225 / Nonmember: $279 / Government: $190
LABORATORY DESIGN:
ESTABLISHING THE FACILITY
AND MANAGEMENT
STRUCTURE
Editor: Scott Sutton
This book is unique in looking
at the question of lab design
from a purely microbiological
perspective and offers concrete
direction to setting up your systems and facilities to
minimize errors and data variability. 2010. Hardcover.
387 pages. Item No. 17294
Member: $280 / Nonmember: $349 / Government: $200
MICROBIAL IDENTIFICATION:
THE KEYS TO A SUCCESSFUL
PROGRAM
Editors: Mary Griffin and Dona
Reber
Here, in one volume, is a unique
compilation rich with vital
information. Mary Griffin and
Dona Reber have assembled
a team of subject matter experts who share their
expertise in this thoughtfully edited volume. 2012.
Hardcover. 452 pages. Hardcover.
Print version: Item No. 17307
Digital version: Item No. 17953
Member: $240 / Nonmember: $299 / Government: $190
6 www.pda.org/bookstore
MICROBIOLOGY IN
PHARMACEUTICAL
MANUFACTURING, SECOND
EDITION, REVISED AND
EXPANDED, VOLUME I AND II
Editor: Richard Prince
The goal of this book is to
provide updated and expanded
microbiological information for
the benefit of a global audience
of stakeholders. 2008. Hardcover. Item No. 17280
Member: $375 / Nonmember: $465 / Government: $250
PHARMACEUTICAL
NEW
OUTSOURCING:
QUALITY MANAGEMENT AND
PROJECT DELIVERY
Editors: Trevor Deeks, Karen
Ginsbury and Susan Schniepp
Intended to set forth and
explore the best practices for
contract organizations from
various perspectives: the contract organization, the
contracting organization and the regulators. The editors
and authors of Pharmaceutical Outsourcing: Quality
Management and Project Delivery have experience
with outsourcing and agreed to collaboratively publish
a comprehensive, practical guide with the goal of
offering sound, reasonable advice to the outsourcing
community focusing mainly on contract manufacturing.
2013. Hardcover. 516 pages. Item No. 17316
Member: $240 / Nonmember: $299 / Government: $210
PRACTICAL ASEPTIC
PROCESSING: FILL AND FINISH,
VOLUME I AND II
Editor: Jack Lysfjord
Aseptic Processing technology
has changed with the use of
advanced aseptic processing
techniques such as blow fill
seals, isolators and restricted
access barrier systems. 2009.
Hardcover. Item No. 17283
Member: $425 / Nonmember: $530 / Government: $290

QUALITY BY DESIGN: PUTTING
THEORY INTO PRACTICE
Editor: Siegfried Schmitt
This book is written with
all stakeholders in mind:
regulatory agencies, the
healthcare industry as well as
suppliers. Quality by Design is
currently the key driver to help
industry bring products to market faster and at the
same time provide maximum assurance of product
quality. 2011. Hardcover. 360 pages. Item No. 17296
Member: $210 / Nonmember: $259 / Government: $155
RAPID STERILITY TESTING
Editor: Jeanne Moldenhauer
In this book you will find a
history of the sterility test
methodology as well as detailed
discussions that provide the
regulatory requirements and
allowances for gaining approval
of rapid sterility test methods.
2011. Hardcover. 501 pages. Item No. 17302
Member: $250 / Nonmember: $309 / Government: $200
RECENT WARNING LETTERS
REVIEW FOR PREPARATION OF
AN ASEPTIC PROCESSING
INSPECTION
Author: Jeanne Moldenhauer
The focus of this book is to
provide a way to prepare for
a FDA inspection of an aseptic
facility by reviewing Warning
Letters recently issued to pharmaceutical companies.
This invaluable guide is a must read for all personnel
involved in any way with the pharmaceutical aseptic
processing inspection process. 2010. Hardcover 194
pages. Item No. 17292
Member: $280 / Nonmember: $349 / Government: $195
PDA BOOKSTORE
RECENT WARNING LETTERS
REVIEW FOR PREPARATION OF
A NON STERILE PROCESSING
INSPECTION, VOLUME 2
Author: Jeanne Moldenhauer
The focus of this book is to
provide a way to prepare for an
FDA inspection of a non-sterile
facility by reviewing relevant
Warning Letters recently issued. 2010. Hardcover. 332
pages. Item No. 17295
Member: $280 / Nonmember: $349 / Government: $195
RISK ASSESSMENT AND RISK
MANAGEMENT IN THE
PHARMACEUTICAL INDUSTRY:
CLEAR AND SIMPLE
Author: James Vesper
This book defines risk,
discusses hazards and risks as
well as tools to evaluate risk.
It provides the background
and context necessary to understand the concept
of risk management detailed in regulatory guidance
documents. 2006. Hardcover. 292 pages. Item No. 17219
Member: $255 / Nonmember: $319 / Government: $160
RISK-BASED SOFTWARE
VALIDATION: TEN EASY STEPS
Authors: Janet Gough and
David Nettleton
This book offers a systematic,
ten-step approach, from the
decision to validate to the
assessment of the validation
outcome for validating
configurable off-the-shelf computer software. 2006.
Hardcover. 183 pages. Item No. 17256
Member: $225 / Nonmember: $279 / Government: $180
www.pda.org/bookstore 7
 Connecting People, Science and Regulation®
SQUARE ROOT OF (N)
NEW
SAMPLING PLANS:
PROCEDURES AND TABLES FOR
INSPECTION OF QUALITY
ATTRIBUTES
Authors: Lynn Torbeck and
Joyce Torbeck
The goal of Lynn and Joyce
Torbeck’s book, Square Root
of (N) Sampling Plans: Procedures and Tables for
Inspection of Quality Attributes, is to show that the
sqrt (N) plans are statistically correct and can be used
in applications that minimize risk to the patient. 2013.
Hardcover. 127 pages. Item No. 17314
Member: $210 / Nonmember: $259 / Government: $170
STERILITY TESTING OF
NEW
PHARMACEUTICAL
PRODUCTS
Author: Tim Sandle
The aim of the book is to
present the sterility test as a
final product release test as
seen in the past, the present
and with a view towards the
future and is aimed at quality assurance personnel,
production staff, microbiologists, students and
those with an interest in medicinal products. 2013.
Hardcover. 379 pages. Item No. 17315
Member: $240 / Nonmember: $299 / Government: $210
THERMAL VALIDATION IN
MOIST HEAT STERILIZATION
Editor: Jeanne Moldenhauer
The various authors cited
in this book have a wealth
of practical experience in
thermal validation of moist
heat sterilization processes
that has been incorporated
into their writing. This book
is an essential guide and reference for managers,
supervisors and all others concerned with preparing
validation plans acceptable to regulators worldwide.
2011. Hardcover. 301 pages. Item No. 17300
Member: $225 / Nonmember: $279 / Government: $180
8 www.pda.org/bookstore
VALIDATING ENTERPRISE
SYSTEMS: A PRACTICAL GUIDE
Author: David Stokes
This book describes the latest
tools, techniques
and regulatory information
needed to validate enterprise
systems. 2012. Hardcover. 467
pages. Item No. 17303
Member: $225 / Nonmember: $279 / Government: $175
VALIDATION BY DESIGN:
THE STATISTICAL HANDBOOK
FOR PHARMACEUTICAL
PROCESS VALIDATION
Author: Lynn Torbeck
This book addresses the
statistical issues expressed and
implied in the U.S. FDA`s Guidance
for Industry Process Validation:
General Principles and Practices, Draft, November 2008.
2010. Hardcover. 222 pages. Item No. 17266
Member: $265 / Nonmember: $329 / Government: $200
WATER ACTIVITY APPLICATIONS
IN THE PHARMACEUTICAL
INDUSTRY
Editors: Anthony (Tony) Cundell
and Anthony Fontana
This book examines the
fundamentals and relationships
of water activity, ranging from
the measurement of moisture
content, water activity, and
water sorption isotherms. 2009.
Hardcover. 308 pages. Item No. 17249
Member: $250 / Nonmember: $309 / Government: $165
back
 PDA BOOKSTORE

PDA Technical Reports

& Resources
PDA Technical Reports are peer-reviewed global consensus documents written by subject matter
experts on issues relating to pharmaceutical and biopharmaceutical production, validation and quality
assurance. They offer expert guidance and opinions on important scientific and regulatory topics and
are used as essential references by industry and regulatory authorities around the world.

For a complete list of PDA Technical Reports, please visit www.pda.org/technicalreports

PDA TECHNICAL SERIES:

STERILIZATION
Member Benefit:
COMPILATION OF
TECHNICAL REPORTS
PDA’s Technical
AND JOURNAL ARTICLES Report Portal
ON PHARMACEUTICAL
STERILIZATION

Digital version: Item No. 43512

Member: $500 / Nonmember: $940 / Government: $300

Hard cover: Item No. 01111 Coming Soon!

Member: $550 / Nonmember: $990 / Government: $350

In PDA’s Technical Report Portal, Standard

PDA TECHNICAL REPORT NO.
33, REVISED 2013 (TR 33)
EVALUATION, VALIDATION AND
IMPLEMENTATION OF
ALTERNATIVE AND RAPID
MICROBIOLOGICAL METHODS
This technical report was written
to establish industry wide
criteria on what constitutes an acceptable alternative or
rapid microbiology test to the compendial or classical
method and how to prove it to the satisfaction of
quality organizations and regulatory agencies. 59 pages.
Print version: Item No. 01033
& Government members will be able to view
all PDA technical reports.
PDA technical reports are highly valued, global
technical documents prepared by member-
driven Task Forces comprised of content experts,
including scientists and engineers working in the
pharmaceutical and biopharmaceutical industry,
regulatory authorities and academia.
We are allowing all PDA Technical Reports to be
viewed through our new portal. After the login
process with member credentials, members will
be able to view the Technical Report documents
(but not print, share or copy these documents).

Member: $250 / Nonmember: $325 / Government: $250 To learn more, visit www.pda.org

Single user digital version: Item No. 43510

Member: $150 / Nonmember: $250 / Government: $75
back
www.pda.org/bookstore 9
 Connecting People, Science and Regulation®
PDA TECHNICAL REPORT NO. 64
(TR 64) ACTIVE TEMPERATURE
CONTROLLED SYSTEMS:
QUALIFICATION GUIDANCE
This guidance discusses the
process of qualifying actively
controlled spaces that are
designed to maintain a stable
and uniform temperature around the cargo for the
duration of transportation or storage at any temperature
range. 58 pages. Print version: Item No. 01064
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43509
Member: $150 / Nonmember: $250 / Government: $75
PDA TECHNICAL REPORT NO.
43, REVISED 2013 (TR 43)
IDENTIFICATION AND
CLASSIFICATION OF
NONCONFORMITIES IN MOLDED
AND TUBULAR GLASS
CONTAINERS FOR
PHARMACEUTICAL
MANUFACTURING: COVERING AMPULES, BOTTLES,
CARTRIDGES, SYRINGES AND VIALS
The 2013 revision of Technical Report No. 43
Identification and Classification of Nonconformities
in Molded and Tubular Glass Containers for
Pharmaceutical Manufacturing provides the building
blocks for developing an overall specification for
molded bottles, vials and tubular glass containers.
190 pages. Print version: Item No. 01043
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43508
Member: $150 / Nonmember: $250 / Government: $75
10 www.pda.org/bookstore
PDA TECHNICAL REPORT NO.
63 (TR 63) QUALITY
REQUIREMENTS FOR THE
EXTEMPORANEOUS
PREPARATION OF CLINICAL
TRIAL MATERIALS
This technical report describes
a quality system that will
support the preparation of clinical trial materials in a
nonmanufacturing environment in a manner that will
ensure product quality and patient safety. 27 pages.
Print version: Item No. 01063
Member: $150 / Nonmember: $250 / Government: $75
Single user digital version: Item No. 43507
Member: $150 / Nonmember: $250 / Government: $75
PDA TECHNICAL REPORT 3,
REVISED 2013 (TR 3)
VALIDATION OF DRY HEAT
PROCESSES USED FOR
DEPYROGENATION AND
STERILIZATION
PDA has revised Technical
Report No. 3, originally issued in
1981. The revision offers a modern, scientific approach
to dry heat depyrogenation and sterilization processes
and includes recommendations for use by industry and
regulators. 40 pages. Print version: Item No. 01003
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43506
Member: $150 / Nonmember: $250 / Government: $75

PDA TECHNICAL REPORT NO.
62 (TR 62) RECOMMENDED
PRACTICES FOR MANUAL
ASEPTIC PROCESSES
The purpose of this technical
report is to outline methods
and approaches for control and
evaluation of aseptic processing
operations for drug products/medicinal products which
use all or partially manual procedures. 30 pages. Print
version: Item No. 01062
Member: $150 / Nonmember: $250 / Government: $75
Single user digital version: Item No. 43505
Member: $150 / Nonmember: $250 / Government: $75
PDA TECHNICAL REPORT NO.
54-2 (TR54-2) IMPLEMENTATION
OF QUALITY RISK MANAGEMENT
FOR PHARMACEUTICAL AND
BIOTECHNOLOGY
MANUFACTURING OPERATION:
ANNEX 1: CASE STUDY
EXAMPLES FOR QUALITY RISK
MANAGEMENT IN PACKAGING AND LABELING
This report is intended to align with ICH Q9 and is
one in a series of similar documents that provide
additional examples of how to apply risk management
tools across the product supply chain. 63 pages. Print
version: Item No. 01054.2
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43504
Member: $150 / Nonmember: $250 / Government: $75
PDA BOOKSTORE
PDA TECHNICAL REPORT NO.
61 (TR 61) STEAM IN PLACE
This technical report
complements PDA Technical
Report No. 1 (Revised 2007):
Validation of Moist Heat
Sterilization Processes:
Cycle Design, Development,
Qualification and Ongoing Control with a focus on
steam in place processes. 61 pages. Print version:
Item No. 01061
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43503
Member: $150 / Nonmember: $250 / Government: $75
PDA TECHNICAL REPORT NO.
60 (TR 60) PROCESS
VALIDATION: A LIFECYCLE
APPROACH
This new technical report, part
of the PCMOsm initiative, will
review requirements for process
validation studies across the
three stage approach defined by FDA and also discuss
best practices for integration with supporting Quality
Systems. 102 pages. Print version: Item No. 01060
Member: $250 / Nonmember: $325 / Government: $250
Single user digital version: Item No. 43502
Member: $150 / Nonmember: $250 / Government: $75
www.pda.org/bookstore 11
 PDA Technical Reports
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 2001 43218

(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 Testing 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)

30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat Revised 2012 43234
(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)

33 Evaluation, Validation and Implementation of New Microbiogical Testing Methods Revised 2013 01033 43510
(Published 2000)

Design and Validation of Isolate Systems for the Manufacturing and Testing
34 2001 01034 43239
of Health Care Products
35 A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry 2001 01035 43240

12 www.pda.org/bookstore
 PDA BOOKSTORE

Paper Digital
TITLE Version Version
36 Current Practices in the Validation of Aseptic Processing – 2001 2002 01036 43241
Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC):
38 2006 01038 43315
Chemistry, Manufacturing and Controls Documentation
Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of
39 2007 01039 43312
Temperature-Sensitive Medicinal Products through the Transportation Environment
40 Sterilization Filtration of Gases 2005 01040 43314
41 Virus Filtration 2008 01041 43313
42 Process Validation of Protein Manufacturing 2005 01042 43311
Identification and Classification of Nonconformities in Molded and Tubular Glass Revised 2013
43 01043 43508
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 43486
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification
48 2010 43487
and Maintenance
49 Points to Consider for Biotechnology Cleaning Validation 2010 43488
50 Alternative Methods for Mycoplasma Testing 2010 43489
Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specifica-
51 2010 43490
tion, Manufacture, Control and Use
52 Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain 2011 43491
53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011 43492
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology
54 2012 43493
Manufacturing Operations
54-2 Implementation of Quality Risk Management for Pharmaceutical and
54-2 Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality 2013 43504
Risk Management in Packaging and Labeling
54-3 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
Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints
55 2012 43494
and Odors in the Pharmaceutical and Consumer Healthcare Industries
Application of Phase-Appropriate Quality Systems and CGMP to the Development
56 2012 43496
of Therapeutic Protein Drug Substance
57 Analytical Method Validation and Transfer for Biotechnology Products 2012 43497
58 Risk Management for Temperature-Controlled Distribution 2012 43499
59 Utilization of Statistical Methods for Production Monitoring 2012 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
63 Quality Requirements for the Extemporaneous Preparation of Clinical Trial 2013 01063 43507
64 Active Temperature-Controlled Systems: Qualification Guidance 2013 01064 43509

This list is current as of November 11, 2013. For a complete list please visit www.pda.org www.pda.org/bookstore 13
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TRANSCRIPT OF THE PROCEEDINGS OF THE 2012
PDA/FDA VACCINE CONFERENCE ON CHALLENGES AND
OPPORTUNITIES FOR PROVIDING VACCINES TO THE WORLD
Transcript of the proceedings of the 2012 PDA/FDA
Vaccine Conference on Challenges and Opportunities
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TRANSCRIPT OF THE PROCEEDINGS OF THE 2013
PDA/FDA GLASS PACKAGING CONFERENCE
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TRANSCRIPT OF THE PROCEEDINGS OF THE 2013
PDA ASEPTIC PROCESSING-STERILIZATION CONFERENCE
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PDA SURVEY: GLASS QUALITY:
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