pda.

org/bookstore

2020 CATALOG

PDA Bookstore
Expert Bio/Pharmaceutical Publications and Resources
for the Pharmaceutical Manufacturing Industry

#PDABookstore
 PDA Technical Books
PDA Technical Books are scientific and regulatory publications specifically
developed for the resource needs of pharmaceutical and biopharmaceutical
professionals. Edited and authored by industry and regulatory experts and thought

Table of leaders, these books are practical guides and references related to specific topics.

Contents Expand your library and increase your knowledge of important industry topics!

PDA Technical Books To help you keep up with a bio/pharmaceutical Aseptic and Sterile Processing: Audit and Control for Healthcare
PAGES 1-15 industry that is progressing at record pace, Control, Compliance and Future Trends Manufacturers: A Systems-Based Approach
EDITORS: Tim Sandle and Edward C. Tidswell AUTHORS: Tim Sandle and Jennifer Sandle
PDA is committed to providing you with the Aseptic and Sterile
PDA Booklets BESTSELLER NEW BESTSELLER Audits
PAGES 16-21
professional tools and resources you need to ASEPTIC AND STERILE
PROCESSING
Processing: Control, Compliance are an important part of
stay current with the latest advances. CONTROL, COMPLIANCE and Future Trends takes a quality assurance and the
PDA Technical Reports
AND FUTURE TRENDS
current and future approach to quality management system.
PAGES 22-29 Our technical books, technical reports, and other two vital processing proce- With the help of PDA’s book,
dures – aseptic and sterile Audit and Control for Healthcare
industry resources are developed by leading manufacturing. 2017. 930 pages. Manufacturers: A Systems-
PDA Surveys
experts in the field. Subject to a rigorous peer- Based Approach, you can
PAGE 30-31
Hardcover: Item No. 17342 | Digital: Item No. 18038 ensure the quality and effectiveness of your
review process, our technical documents are
The PDA Journal of sound and reflective of industry best practice.
M $260 | NM $325 | G $240 processes, systems, and personnel is maintained
throughout your organization! 2019. 862 pages.
Pharmaceutical Science Many of our publications quickly become
and Technology Assuring Data Integrity for Life Sciences Hardcover: Item No. 17351 | Digital: Item No. 18059
PAGE 32
bestsellers, and our technical reports are M $240 | NM $299 | G $220
EDITOR: Siegfried Schmitt
recognized by industry professionals around the BESTSELLER This book provides
world as highly valuable resources. a truly global perspective on Biofilm Control in Drug Manufacturing
data integrity and the solutions EDITORS: Lucia Clontz and Carmen M. Wagner
In this rapidly evolving industry, knowledge available to address this
This book provides guidance
serious issue. It includes two
is your most important asset! Find all of the for preventing and controlling
main sections: the regulatory
information you need in PDA’s vast inventory of biofilm contamination in
and historic background of
pharmaceutical and
resources at pda.org/bookstore. data integrity, and practical
biopharmaceutical processing.
advice on how to prevent or rectify data
2012. 496 pages.
integrity breaches. 2016. 408 pages.
Digital: Item No. 17986
Hardcover: Item No. 17335 | Digital: Item No. 18016
M $265 | NM $329 | G $220 M $240 $192 | NM $299 $239 | G $190 $152

Biological Indicators for Sterilization

Processes
EDITORS: Margarita Gomez and Jeanne Moldenhauer
2008. 536 pages
Hardcover: Item No. 17268
M $280 $196 | NM $349 $245 | G $190 $140

LEGEND: M = Member Pricing | NM = Nonmember Pricing | G = Government Pricing

2 www.pda.org/bookstore 1
 Biotechnology: From Idea to Market Cleaning Validation: Practical Compliance Cleanroom Microbiology Computerized Systems in the Modern

2020 PDA PUBLICATIONS CATALOG

EDITORS: Fred Mermelstein, Richard Prince, Carl Solutions for Pharmaceutical AUTHORS: Tim Sandle and R. Vijayakumar Laboratory: A Practical Guide
PMSNovina
CMYK RGB Hex code for Web Manufacturing, Volume 4 BESTSELLER This book is AUTHOR: Joseph G. Liscouski
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
NEW An invaluable
BESTSELLER AUTHOR: Destin A. LeBlanc CLEANROOM about cleanrooms and This book provides laboratory
guide and reference for anyone Volume 4 complements Destin MICROBIOLOGY controlled environments in staff and managers with a
involved in the development of LeBlanc’s earlier three books on relation to the pharmaceutical solid understanding of the
a product, from idea generation the same subject. This book and healthcare sectors. With its tools available, how to
through commercialization. The modifies and updates LeBlanc’s focus on cleanroom microbiol- successfully purchase and
goal of this book is to provide monthly Cleaning Memos ogy, this book is applicable to
Tim Sandle and R. Vijayakumar
implement the technology, and
a comprehensive overview for originally published from January both the sterile and non‑sterile how to develop a plan for
students and professionals 2013 through December 2016. pharmaceutical sectors. 2014. 600 pages. application and evaluation in
alike in how to think about and to navigate the More than half of the chapters in order to meet regulatory requirements.
Hardcover: Item No. 17326 | Digital: Item No. 17983
necessary development process for healthcare the book address setting limits in one way or 2015. 432 pages
product candidates, including biologics, new another, so the use of health-based limits will
M $240 | NM $299 | G $210
Hardcover: Item No. 17329 | Digital: Item No. 18003
chemical entities, and other related products that require balanced reading (and thinking) for an
address medical need. This instructional text overall understanding. 2017. 253 pages. Cold Chain Chronicles: A practitioner’s M $265 $212 | NM $329 $263 | G $210 $168
enables anyone at any level or in any sector of outside-the-box perspectives on the
Digital: Item No. 18027
the industry to easily achieve a basic knowledge importance of temperature-sensitive drug
of the critical steps (or the questions to ask) to M $240 | NM $299 | G $210
stewardship Confronting Variability: A Framework for
properly evaluate an idea or technology, develop AUTHOR: Kevin O’Donnell
Risk Assessment
a viable product candidate, and ultimately Cleaning Validation: Practical Compliance EDITORS: Diane Petitti and Richard Prince
Noted pharmaceutical
advance it to the marketplace. 2019. 1064 pages. Solutions for Pharmaceutical Manufacturing, 2007. 222 pages
cold‑chain expert Kevin

TECHNICAL BOOKS
Hardcover: Item No. 17352 | Digital: Item No. 18060 Volumes 1, 2, and 3 O’Donnell relates a series of Hardcover: Item No. 17244
AUTHOR: Destin A. LeBlanc
M $295 | NM $369 | G $295 engaging stories carefully M $280 $196 | NM $349 $245 | G $195 $140
The three volumes that crafted to elevate awareness,
make up Cleaning Validation: understanding, and criticality
Cleaning and Cleaning Validation,
Practical Solutions for of temperature‑sensitive drug Contamination Control in Healthcare
Volumes 1 and 2
Pharmaceutical Manufacturing products throughout the supply Product Manufacturing, Volume 5
EDITOR: Paul L. Pluta
contain a complete, modified, chain, not only for the stakeholders involved, but EDITORS: Russell E. Madsen and
Cleaning and Cleaning and updated collection also for the consumer in us all. 2014. 182 pages Jeanne Moldenhauer
Validation is a series of the author’s Cleaning Hardcover: Item No. 17323 | Digital: Item No. 17980
of volumes presenting BESTSELLER The fifth volume
Memos. In all volumes, each
current knowledge and Cleaning Memo is presented
M $210 $168 | NM $259 $207 | G $190 $152 in PDA’s popular series,
approaches to cleaning as a chapter, with the chapters re‑organized by Contamination Control in
and cleaning validation of common topics rather than chronologically as Combination Products: Implementation of Healthcare Product
pharmaceuticals, medical they appear in the original format. The benefit cGMP Requirements Manufacturing, explores
devices, and associated to having three volumes at hand, in addition to practical approaches to
EDITOR: Lisa A. Hornback
products, consistent with gaining full insight into 12 years of subject matter leverage environmental
This book explores the unique monitoring data to improve
current regulatory documents and expectations. expert advice, is the accessibility of information by aspects and considerations performance, how to design a risk-based
Case studies presented throughout the volumes common subject. 2013. for implementation of cGMP environmental monitoring program for non-
supplement basic information with useful real-
Digital: Item No. 17981 in a combination product sterile manufacturing, the clinical relevance of
life experiences. 2013.
environment. It includes
Digital: Item No. 17987
M $635 $508 | NM $790 $632 | G $435 $348
comprehensive information
objectional microorganisms, and much more!.
2018. 510 pages.
Available for Individual Purchase
M $535 $428 | NM $670 $536 | G $465 $372 from leaders in the industry
Hardcover: Item No. 17350 | Digital: Item No. 18055
Volume 1 (Digital: Item No. 18033) regarding the unique
Volume 2 (Hardcover: Item No. 17289 Digital: Item No. 18034) requirements for several common combination M $240 | NM $299 | G $210
Volume 3 (Hardcover: Item No. 17310 Digital: Item No. 18035) products situations. 2013. 200 pages
M $265 $212 | NM $329 $263 | G $180 $144 Digital: Item No. 17951
M $210 $168 | NM $259 $207 | G $170 $136

2 www.pda.org/bookstore 3
 Contamination Control in Healthcare Contamination Prevention for Nonsterile Encyclopedia of Rapid Microbiological Environmental Monitoring: A Comprehensive

2020 PDA PUBLICATIONS CATALOG

Product Manufacturing, Volume 4 Pharmaceutical Manufacturing Methods, Volumes 1, 2, and 3 Handbook, Volumes 1, 2, and 3
EDITORS:
PMS CMYK
Russell E. Madsen
RGB
and Hex code for Web
AUTHOR: Andrew Dick EDITOR: Michael J. Miller EDITOR: Jeanne Moldenhauer
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
Jeanne Moldenhauer This handbook on Contamination Regulatory bodies worldwide
Introductory volumes of
This book is an essential Prevention for Nonsterile the Encyclopedia of have all established standards
complement to any Pharmaceutical Manufacturing Rapid Microbiological and guidelines for environ-
contamination control library! offers guidelines for best Methods series mental control. Unfortunately,
Volume 4 is a useful reference practices to be deployed within a describes the rapid the requirements are not
guide when combined with the manufacturing facility. It explains methods currently equivalent across documents
previous three volumes. 2016. where the most common available and focuses and nations. These three
402 pages. microbiological risks to nonsterile on regulatory initiatives volumes describe methods
manufacturing reside and how to prevent currently in place that for developing and operating
Hardcover: Item No. 17336 | Digital: Item No. 18017 contamination in key areas. Designed for easy will help pharmaceuti- an appropriate, sustainable microbiological program
reading, this practical guide walks readers through cal microbiologists begin the journey of for production and the laboratory.
M $240 | NM $299 | G $210
decision-making steps, including how to set up a implementing rapid microbiological methods in Digital: Item No. 18007
facility, what types of equipment to acquire, how to their facilities. 2005/2006.
maintain it, and how to clean and sanitize
M $800 $640 | NM $1,000 $800 | G $700 $560
Contamination Control in Healthcare Digital: Item No. 17989
equipment and facilities. 2018. 119 pages.
Product Manufacturing, Volumes 1, 2, and 3
Digital: Item No. 48002 M $795 $636 | NM $989 $791 | G $685 $548 Environmental Monitoring: A Comprehensive
EDITORS: Russell E. Madsen and Handbook, Volumes 4, 5, 6, and 7
Jeanne Moldenhauer
M $210 | NM $259 | G $190
EDITOR: Jeanne Moldenhauer
Fifty global subject matter Environmental Monitoring: A The Environmental

TECHNICAL BOOKS
experts share their broad Effective Implementation of Audit Programs Comprehensive Handbook, Volume 8 Monitoring series, edited by
CONTAMINATION
experiences in all aspects AUTHOR: Miguel Montalvo EDITOR: Jeanne Moldenhauer Jeanne Moldenhauer,
CONTROL IN
HEALTHCARE of healthcare product This well-researched text is a BESTSELLER Volume 8 provides guidance through
PRODUCT
MANUFACTURING manufacturing contamina- must have for personnel involved of the Environmental the ins and outs of the
tion control in this
Volume 2
in the implementation and Monitoring Handbook multitudinous aspects of
three‑volume set. The first execution of critical programs, series is a mixture of new compliance. This collection
volume contains chapters
Russell E. Madsen and Jeanne Moldenhauer
Editors
auditors, auditees, and topics and new takes on of volumes is a must have for
that are predominantly outsourcing providers! previously discussed anyone involved with environ-
centered on microbial 2017. 390 pages. topics. In this Volume, you mental monitoring concerns.
issues. Volume 2 addresses some microbial will find information about Digital: Item No. 18006
issues, but also focuses on other types of Hardcover: Item No. 17340 | Digital: Item No. 18026
regulatory/compendial updates, testing $1,070 $856 | $1,340 $1,072 | $930 $744
contamination. Volume 3 discusses extensive M $210 | NM $259 | G $190
methods, risk methods and tools, and routine
M NM G

subjects in aseptic contamination control. 2014. (and non-routine) monitoring. This Volume Environmental Monitoring: A Comprehensive
Encyclopedia of Rapid Microbiological Handbook, Volumes 4, 5, 6, and 7
Digital: Item No. 17976 is a must have for anyone involved with
items for Individual Purchase
Methods, Volume 4 environmental monitoring! 2017. 257 pages.
M $580 | NM $720 | G $510
EDITOR: Michael J. Miller Volume 1 (Digital: Item No. 17977) Hardcover is not available
Hardcover: Item No. 17343 | Digital: Item No. 18039
Volume 2 (Digital: Item No. 17978)
Available for Individual Purchase This volume complements the
author’s previous three volumes
M $260 | NM $325 | G $240
Volume 3 (Digital: Item No. 17979) Hardcover is not available
Volume 1 (Hardcover: Item No. 17311
Digital: Item No.17952) by offering new techniques, case Volume 4 ( Hardcover: Item No. 17291 Digital: Item No. 18008)
studies, new equipment, and Volume 5 (Hardcover: Item No. 17299 Digital: Item No. 18009)
Volume 2 (Hardcover: Item No. 17317
Digital: Item No.17974) much more. Details about quality Volume 6 (Digital: Item No. 18010)
control, choosing appropriate Volume 7 ( Hardcover: Item No. 17325 Digital: Item No. 18011)
Volume 3 (Digital: Item No.17975)
methods, future use and
M $335 $268 | NM $419 $335 | G $290 $232
M $240 | NM $299 | G $210 technologies, and mass
spectrometry are included. 2013. 608 pages.
Hardcover: Item No. 17308 | Digital: Item No. 17988 Protocol CD in PDF format (Item No. 18056)
M $335 $268 | NM $419 $335 | G $290 $232 M $75 $60 | NM $89 $71 | G $45 $36

4 www.pda.org/bookstore 5
 Essential Microbiology for QP Candidates Global Sterile Manufacturing Regulatory Good Distribution Practice: A Handbook Laboratory Design: Establishing the

2020 PDA PUBLICATIONS CATALOG

AUTHOR: Nigel Halls Guidance Comparison for Healthcare Manufacturers and Facility and Management Structure
PMS CMYK
2007.C:100
314 pages.
RGB Hex code for Web
The Global Sterile Suppliers, Volume 1 AUTHOR: Scott Sutton
301 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
Hardcover: Item No. 17265 | Digital: Item No. 18024 Manufacturing Regulatory EDITOR: Siegfried Schmitt 2010. 391 pages. Digital: Item No. 18002

M $250 $175 | NM $309 $220 | G $180 $130

Guidance Comparison – With NEW Following an introduc- M $196 | NM $245 | G $140
link to Comparison tion to the subject of Good
Spreadsheet compares Distribution Practice (GDP),
regulatory guidance the first volume of this book Lessons of Failure: When Things Go
Ethylene Oxide Sterilization Validation and
documents issued by the covers key topics related to Wrong in Pharmaceutical Manufacturing
Routine Operations Handbook
AUTHOR: Anne F. Booth
U.S. FDA, the EU, the five main points: the applicable EDITORS: Russell E. Madsen and Maik W. Jornitz
Pharmaceutical Inspection Convention/ GDP regulations worldwide, In Lessons of Failure When
2007. 203 pages.
Scheme, and the World Health Organization. including serialization; an Things Go Wrong in
Digital: Item No. 17942
2016. 99 pages. overview of the requirements of Qualified Pharmaceutical Manufacturing,
M $225 | NM $279 | G $180
Softcover: Item No. 03006 Persons and Responsible Persons in GDP; GDP world-renowned experts share
as part of the Quality Management System; an their global work experiences
M $250 | NM $375 | G $250
industry perspective on GDP; and a practical to highlight root cause
Fungi: A Handbook for Life Science Digital: Item No. 48000
Manufacturers and Researchers GDP checklist. 2019. 578 pages. analysis and problem solving.
EDITOR: Jeanne Moldenhauer
M $180 | NM $325 | G $180
Hardcover: Item No. 17353 | Digital: Item No. 18061 The stories are not only
This text can help identify
NEW
M $210 | NM $259 | G $210 examples of what can go wrong, but also
GMP in Practice: Regulatory Expectations contain key points to take away and apply. For
and ameliorate fungal and mold
for the Pharmaceutical Industry, Fifth those who provide GMP and quality training, this
problems and contains a wealth of Good Distribution Practice: A Handbook
Edition, Revised and Expanded book is a goldmine. 2015. 299 pages.

TECHNICAL BOOKS
information as a guide and for Healthcare Manufacturers and
AUTHOR: James L. Vesper and Tim Sandle Digital: Item No. 18013
reference. Many topics are Suppliers, Volume 2
discussed relevant to the food and GMP in Practice:
BESTSELLER
EDITOR: Siegfried Schmitt M $210 | NM $259 | G $190
agriculture industries, including Regulatory Expectations for the
NEW Following an introduction
the biology of fungi, outbreaks Pharmaceutical Industry, Fifth
to the subject of Good Lifecycle Risk Management for Healthcare
associated with pharmaceutical drug products and Edition, Revised and Expanded
Distribution Practice (GDP), in Products: From Research through
medical devices, mycotoxins, fungal biodegradation examines 34 elements that are
the second volume, dive into Disposal
and remediation, and strategies for a rapid and typically included in a modern
supply-chain risk mitigation, EDITORS: Edwin Bills and Stan Mastrangelo
accurate fungal identification. The text also pharmaceutical quality
serialization, and packaging as This book provides current
contains a lengthy fungal glossary. system, including Data
it relates to risk assessments. information on the risk
2019. 813 pages. Integrity. Each quality system element has an
This text and its companion management process as it
overview section, some risk-related questions,
Hardcover: Item No. 17355 / Digital: Item No. 18063 Volume 1 will help drive down costs and improve
and 3-10 expectations. Each expectation is applies to health and safety of
M $240 | NM $299 | G $240
explored in more detail, and examples are
efficiency. 2019. 420 pages. health products, drugs and
provided from GMP references, including the Hardcover: Item No. 17354 | Digital: Item No. 18062 biologics, and medical devices
U.S. FDA, Health Canada, the European Union, M $210 | NM $259 | G $210 and products that are a
the World Health Organization, and the combination of two or more of
International Conference on Harmonization Hosting a Compliance Inspection these. The application of the processes will
(ICH). 2018. 690 pages. AUTHOR: Janet Gough help manufacturers of these products to create
Hardcover: Item No. 17349 | Digital: Item No. 18054 2001. 120 pages. Digital: Item No. 17923 and maintain products that are at an
acceptable level of safety for society through
M $240 | NM $299 | G $220 M $145 $87 | NM $179 $108 | G $80 $48
the product lifecycle. 2016. 295 pages.
Hardcover: Item No. 17338 | Digital: Item No. 18019
Introduction to Environmental Monitoring
in Pharmaceutical Areas
M $225 | NM $279 | G $190

AUTHOR: Michael Jahnke

2001. 114 pages. Digital: Item No. 17925
M $72 | NM $93 | G $51

6 www.pda.org/bookstore 7
 Media Fill Validation Environmental Microbial Identification: The Keys to a Microbiological Culture Media: A Microbiology in Pharmaceutical

2020 PDA PUBLICATIONS CATALOG

Monitoring During Aseptic Processing Successful Program Complete Guide for Pharmaceutical and Manufacturing, Second Edition,
PMSAUTHOR:
CMYK Michael Jahnke
RGB Hex code for Web EDITORS: Mary Griffin and Dona Reber Healthcare Manufacturers Revised and Expanded, Volumes 1 and 2
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
2001. 114 pages. Digital: Item No. 17924 AUTHOR: Tim Sandle EDITOR: Richard Prince
The Editors of this book
M $120 $72 | NM $155 $93 | G $85 $72 assembled a team of subject Taking into account that 90 The first edition
matter experts who share their MICROBIOLOGICAL
percent of quality control of Microbiology in
CULTURE MEDIA

expertise on microbial AC G
OMPLETE
microbiology remains reliant
UIDE Pharmaceutical
Method Development and Validation for identifications (IDs) in this
P
FOR HARMACEUTICAL
Manufacturing, published
upon culture-based methods,
H
AND EALTHCARE
M
the Pharmaceutical Microbiologist
ANUFACTURERS

thoughtfully edited volume. this unique text focuses on in 2001, is the best-selling
AUTHOR: Crystal Booth This invaluable book includes microbiological culture media PDA/DHI book of all time.
The purpose of this book is to details about viral and as applied to pharmaceutical
Tim Sandle
The completely revised
inspire ideas and provide mycoplasma ID methods, challenges and case microbiology. This book takes and extended edition
recommendations regarding studies on fungal IDs, use of science-based risk into consideration that innovations continue to raises the bar by offering
method development and assessment for objectionable organisms, arise with new media recipes that are practical and current industrial and regulatory
validation strategies for microbial IDs for medical devices and formulated for the selection of new strains for perspectives. Twenty new chapters were added
pharmaceutical microbiolo- cosmetics, and much more. 2012. 447 pages. the application of media in conjunction with and 16 new authors contributed their expertise to
gists. The book may also aid rapid microbiological methods. In 23 chapters, provide updated and expanded microbiological
Digital: Item No. 17953 information for the benefit of a global audience
microbiologists who are the book covers how media is used in the
starting new facilities or validating equipment.
M $240 $192 | NM $299 $239 | G $190 $152
modern pharmaceutical microbiology setting of stakeholders. 2008.
This is a must-have resource for anyone and recaps the past, signals the future, and Digital: Item No. 17991
engaged in the many aspects of method helps interpret the present. 2017. 582 pages.
development and validation in pharmaceutical Microbial Risk and Investigations
M $375 $300 | NM $465 $372 | G $250 $200

TECHNICAL BOOKS
Hardcover: Item No. 17345 | Digital: Item No. 18041
microbiology. 2017. EDITORS: Karen Zink McCullough and Available for Individual Purchase
Hardcover: Item No. 17339 | Digital: Item No. 18022
Jeanne Moldenhauer M $240 | NM $299 | G $210
Volume 1 (Digital: Item No. 18051)
This book provides
M $210 | NM $259 | G $190
BESTSELLER
a wealth of information on
Volume 2 (Digital: Item No. 18052)
Microbiological Monitoring of
microbial investigations and
Pharmaceutical Process Water
M $235 $188 | NM $289 $231 | G $155 $124
dealing with aberrant data.
Microbial Control and Identification: AUTHOR: Michael Jahnke
Many of the chapters include
Strategies Methods Applications 2002. 70 pages.
case studies that can provide
EDITORS: Dona Reber and Mary Griffin Digital: Item No. 17919 PDA Technical Series: Endotoxin Analysis
guidance for common
and Risk Management
BESTSELLER The Editors of this situations that may occur M $120 | NM $149 | G $95
NEW PDA Technical Series:
book assembled a team of at your facility. 2015. 867 pages.
subject matter experts who Endotoxin Analysis and Risk
Hardcover: Item No. 17328 | Digital: Item No. 18005
PDA Technical Series:
Endotoxin Analysis and
Risk Management

share their expertise on Management is a collection of

microbial identifications (IDs)
M $260 | NM $325 | G $240
published research on the
in this thoughtfully edited topic from the PDA Journal of
Includes articles on

Pharmaceutical Science and

Low Endotoxin Recovery

volume. This invaluable book Microbial Risk Assessment in

includes details about viral and Pharmaceutical Clean Rooms Technology. This volume is
mycoplasma ID methods, challenges and case intended for those in the
AUTHORS: Berit Reinmueller and Bengt Ljungqvist
studies on fungal IDs, use of science-based risk industry who perform and/or are responsible
2001. 17 pages. Digital: Item No. 17920
assessment for objectionable organisms, for the quality testing and manufacture of
microbial IDs for medical devices and
M $95 | NM $119 | G $75 biopharmaceutical products. For those
cosmetics, and much more. 2018. 592 pages. concerned with the phenomenon of “Low
Endotoxin Recovery,” two articles from the PDA
Hardcover: Item No. 17347 | Digital: Item No. 18043 Journal are included. 2019. 170 pages.
M $240 | NM $299 | G $220
Digital: Item No. 48004
M $150 | NM $250 | G $120

8 www.pda.org/bookstore 9
 PDA Technical Series: Pharmaceutical Glass Pharmaceutical Outsourcing: Quality Phase Appropriate GMP for Biological Practical Aseptic Processing Fill and

2020 PDA PUBLICATIONS CATALOG

The PDA Technical Series: Management and Project Delivery Processes: Pre-Clinical to Commercial Finish, Volumes 1 and 2 (continued)
PMS CMYK Pharmaceutical
RGB Glass
Hex code for is
Weba
EDITORS: Trevor Deeks, Karen Ginsbury, and Production Available for Individual Purchase
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
collection of articles previously Susan Schniepp EDITOR: Trevor Deeks
Volume 1 (Digital: Item No. 18036)
published in the PDA Journal of This book provides
This book is intended to set BESTSELLER Volume 2 (Hardcover: Item No. 17255
Pharmaceutical Science and succinct and practical Digital: Item No. 18037)
forth and explore the best
Technology. This compilation guidance on how to develop
organizes 19 articles on glass
practices for contract M $265 $212 | NM $329 $263 | G $180 $144
organizations from various a biological drug product and,
published between 2007 and at the same time, stay within
perspectives: the contract
2017 into four categories: Overview, Material the regulatory expectations Quality by Design: Putting Theory into
organization, the contracting
Composition, Delamination, and Quality Methods. at each phase of the Practice
organization, and the
A decade ago, the focus on the quality of phar- regulators. The editors and development process! EDITOR: Siegfried Schmitt
maceutical glass was sharpened with a series of authors have experience with outsourcing and Within this book, you can find chapters on: This book is written with all
product recalls due to findings of glass partic- have published a comprehensive, practical •C  urrent manufacturing and process stakeholders in mind, including
ulates in finished products. The PDA Technical guide with the goal of offering sound, development of Regenerative Medicine regulatory agencies, the
Series: Pharmaceutical Glass shows that much reasonable advice to the outsourcing Advanced Therapy Products (RMATs), or as healthcare industry, and
work has been done to help understand this issue community, focusing mainly on contract they are known in the EU, Advanced Therapy suppliers. The process of
and other quality issues pertaining to glass. manufacturing. 2013. 518 pages. Medicinal Products (ATMPs) adoption, implementation, and
•Q  uality systems and GMP requirements for interpretation of quality by
The publication of this book supports a major ini- Digital: Item No. 17992
Phase 1 to Phase 3 manufacturing design is currently the key
tiative launched by PDA in 2017 to connect phar- M $240 | NM $299 | G $210
• The impact of the Clinical Trials Directive driver helping the industry bring products to
maceutical manufacturers and glass suppliers to
market faster and, at the same time, providing

TECHNICAL BOOKS
prepare for complex products and manufacturing on European GMP expectations and the role
of the QP maximum assurance of product quality.
processes of the future. 2018. 225 pages.
Pharmaceutical Quality • The latest USP guidance on the transfer of 2011. 360 pages.
Digital: Item No. 48003
EDITOR: Richard Prince analytical methods, validation and verification Digital: Item No. 17985
M $150 | NM $250 | G $120 2004. 758 pages of compendial procedures M $210 $168 | NM $259 $207 | G $155 $124
Hardcover: Item No. 17207 • And, much more
Pharmaceutical Contamination Control:
Practical Strategies for Compliance
M $320 $225 | NM $399 $280 | G $210 $150 2018. 525 pages.
Radiation Sterilization: Validation and
Hardcover: Item No. 17346 | Digital: Item No. 18042
EDITOR: Nigel Halls Routine Operations Handbook
2007. 289 pages. M $240 | NM $299 | G $220 AUTHOR: Anne F. Booth
Pharmaceutical Quality Control
Hardcover: Item No. 17246 2008. 183 pages.
Microbiology: A Guidebook to the Basics
M $280 $196 | NM $349 $245 | G $190 $140
AUTHOR: Scott Sutton Practical Aseptic Processing Fill and
Hardcover: Item No. 17277

2007. 205 pages Finish, Volumes 1 and 2 M $225 $158 | NM $279 $200 | G $180 $130
Pharmaceutical Legislation of the European Digital: Item No. 18025 EDITOR: Jack Lysfjord
Union, Japan and the United States of
America ‑ An Overview, Updated and
M $235 $165 | NM $289 $200 | G $155 $110 Aseptic processing
Rapid Sterility Testing
technology has changed
Expanded Second Edition EDITOR: Jeanne Moldenhauer
with the use of advanced
EDITOR: Barbara Jentges In this book, you will find a
aseptic processing
The book presents a condensed history of the sterility test
techniques such as
overview of the regulatory methodology and detailed
blow-fill-seal isolators and
systems and processes for discussions that provide the
restricted access barrier
marketing a drug product in the regulatory requirements and
systems. This book
three major global regions: allowances for gaining
explores these changes
Japan, the United States, and the approval of rapid sterility test
and how they impact aseptic processing. 2009.
European Union. 2016. 164 pages. methods. 2011. 501 pages.
Digital: Item No. 17993
Hardcover: Item No. 17302 | Digital: Item No. 17994
Hardcover: Item No. 13011 | Digital: Item No. 48001 M $425 $340 | NM $530 $424 | G $290 $232
M $250 $200 | NM $309 $247 | G $200 $160
M $150 | NM $180 | G $120

10 www.pda.org/bookstore 11
 Recent Warning Letters: Review for Risk Assessment and Risk Management SOPs Clear and Simple: For Healthcare Steam Sterilization: A Practitioner’s Guide

2020 PDA PUBLICATIONS CATALOG

Preparation of an Aseptic Processing in the Pharmaceutical Industry: Clear and Manufacturers EDITOR: Jeanne Moldenhauer
PMSInspection, Volume
RGB 1 Simple AUTHORS: Susan Schniepp, Brian Matye and
CMYK Hex code for Web
2002. 740 pages.
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
AUTHOR: Jeanne Moldenhauer AUTHOR: James L. Vesper Jeanne Moldenhauer Hardcover: Item No. 17183
2010. 195 pages. 2006. 292 pages.
NEW BESTSELLER There are M $118 | NM $150 | G $118
Digital: Item No. 18020 Digital: Item No. 17995
four simple sentences that
M $280 $196 | NM $349 $245 | G $195 $140 M $255 $204 | NM $319 $255 | G $160 $128 define the concept of
Sterility Testing of Pharmaceutical Products
compliance and its
AUTHOR: Tim Sandle
relationship to Standard
Recent Warning Letters: Review for Risk-Based Compliance Handbook This book presents the sterility
Operating Procedures (SOPs)
Preparation of a Non‑Sterile Processing AUTHOR: Siegfried Schmitt test as a final product release
– Say what you do. Do what
Inspection, Volume 2 2008. 188 pages. test as seen in the past, the
you say. Prove it. Improve it.
AUTHOR: Jeanne Moldenhauer Digital: Item No. 17973 present, and with a view
Despite this concept seeming simple, the num- toward the future. It is de-
2010. 332 pages.
Digital: Item No. 18021
M $168 | NM $210 | G $130 ber one topic of 483 observations for biologics, signed for quality assurance
drugs, and devices from 2013 through 2017 personnel, production staff,
M $280 $196 | NM $349 $245 | G $195 $140
Risk-Based Software Validation:
included failure to follow SOPs, procedures not microbiologists, students, and
in writing, and lack of adequate procedures. those with an interest in medicinal products.
Ten Easy Steps
In this comprehensive guide, gain practical in- 2013. 379 pages.
Risk Assessment and Management AUTHORS: Janet Gough and David Nettleton
sight into the need for SOPs, how to write them, Digital: Item No. 17996
for Healthcare Manufacturing: Practical This book offers a systematic, and what should be included in them. Explore
Tips and Case Studies 10-step approach, from the M $240 $192 | NM $299 $239 | G $210 $168
the application of SOPs to the pharmaceutical,

TECHNICAL BOOKS
AUTHOR: Tim Sandle decision to validate to the biotechnology, and medical device industries.
BESTSELLER The book is
assessment of the validation This useful text offers a simple, yet, straightfor- Systems Based Inspection for
divided into four sections that outcome, for validating ward approach to writing SOPs, highlighting their Pharmaceutical Manufacturers
present a formal approach to configurable, off-the-shelf importance in maintaining compliant operations
computer software that EDITOR: Jeanne Moldenhauer
risk. Sections focus on risk critical to manufacturing quality products.
generates data or controls 2007. 398 pages.
assessment and hazards; Upon finishing this book, you’ll be able to not Digital: Item No. 17972
common risk assessment information about products and processes only write out SOPs but also follow them to
tools and problem‑solving subject to binding regulations. 2006. 183 pages. fully maintain compliance. 2019. 177 pages. M $224 | NM $280 | G $156
approaches; “soft skills” that Digital: Item No. 18064 Hardcover: Item No. 17348 | Digital: Item No. 18053
help in conducting risk assessments; and case
studies exploring the problems and events that
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Keys to Successful Implementation and
occur with pharmaceuticals and healthcare,
Management
against which the reader can consider real‑life
Square Root of (N) Sampling Plans: EDITORS: Mark Gibson and Siegfried Schmitt
problems. The wide range of topics covered
Procedures and Tables for Inspection of
includes risk considerations for aging Written by global subject
Quality Attributes
pharmaceutical facilities, application of quality matter experts, this book
AUTHORS: Joyce Torbeck and Lynn Torbeck offers the practical experience
risk management to cleanroom design, and
process incident investigation. 2016. 730 pages. The goal of Joyce and Lynn needed to obtain a competitive
Hardcover: Item No. 17337 | Digital: Item No. 18018 Torbeck’s book is to illustrate edge. This book will help
that the square root of (N) companies take a proactive
M $240 | NM $299 | G $210
plans are statistically correct approach to streamlining and
and can be used in applications optimizing their technology
that minimize risk to patients. transfer processes to ensure successes.
2013. 127 pages. 2014. 474 pages.
Hardcover: Item No. 17314 | Digital: Item No. 17982 Digital: Item No. 17984
M $210 $168 | NM $259 $207 | G $170 $136 M $265 | NM $329 | G $210

12 www.pda.org/bookstore 13
 The Bacterial Endotoxins Test: Torbeck’s Statistical Cookbook for Validating Enterprise Systems: Visual Inspection and Particulate Controls

2020 PDA PUBLICATIONS CATALOG

A Practical Guide Scientists and Engineers A Practical Guide AUTHORS: D. Scott Aldrich, Roy T. Cherris, and
EDITOR:
PMS CMYK
Karen Zink McCullough
RGB Hex code for Web
AUTHOR: Lynn D. Torbeck AUTHOR: David Stokes John G. Shabushnig
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This unique book is a In the Statistical Cookbook for This book describes the latest BESTSELLER This book is a
collection of interdependent Scientists and Engineers, you tools, techniques, and regula- practical guide for the control
chapters that are part lab will find tried and true, tory information needed to of visible defects and contami-
manual, part essay, part practical statistical “recipes” validate enterprise systems. nation in pharmaceutical
historical context, part that provide a book of specific 2012. 467 pages. products. It is intended for
consultant, and part plain-sage and unique statistical modules Hardcover: Item No. 17303 product inspectors and lab
advice that provides a useful for evaluation of Digital: Item No. 18000 support personnel and for
practical and compliant industrial studies. These those who use inspection
approach to the execution and use of the modules are designed for the busy industrial M $225 $180 | NM $279 $223 | G $175 $140 results or are responsible for inspection
bacterial endotoxins test. 2011. 434 pages. worker, who needs to apply statistical operations. Meant to educate seasoned
techniques with the assurance he or she is inspectors on the principles of microscopy and
Hardcover: Item No. 17297 | Digital: Item No. 17997 familiarize seasoned microscopists with the
using the technique correctly. Validation by Design: The Statistical
M $210 | NM $259 | G $165 2017. 241 pages. Handbook for Pharmaceutical Process elements of visual inspection, this book
Validation describes ways to find visible defects and what
Hardcover: Item No. 17344 | Digital: Item No. 18040 to do with them once found. 2016. 373 pages.
The External Quality Audit AUTHOR: Lynn Torbeck

AUTHORS: Janet Gough and Monica Grimaldi

M $210 | NM $259 | G $190
2010. 225 pages. Digital: Item No. 17999 Hardcover: Item No. 17334 | Digital: Item No. 18015

2001. 122 pages. M $185 | NM $230 | G $150 M $240 | NM $299 | G $210

Digital: Item No. 17922 Trend and Out‑of‑Trend Analysis

TECHNICAL BOOKS
M $145 | NM $179 | G $85 for Pharmaceutical Quality and Why Life Science Manufacturers Do What
Manufacturing Using Minitab® Validation Master Plan: The Streetwise They Do in Development, Formulation,
AUTHOR: Lynn D. Torbeck
Downtown Guide Production and Quality: A History
The Internal Quality Audit AUTHOR: Trevor Deeks
This book is for pharmaceutical AUTHOR: Lynn D. Torbeck
AUTHORS: Monica Grimaldi and Janet Gough 2002. 49 pages. Digital: Item No. 17927
professionals working in In a passionate retrospective
2001. 100 pages.
Digital: Item No. 17921 product discovery, develop- M $120 | NM $149 | G $95 of a successful career built on
ment, manufacturing, quality thinking statistically and
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assurance, and quality control. applying that approach to
It presents a basic introduction Validation of Analytical Methods quality in pharmaceutical
Thermal Validation in Moist Heat to data, trend, and out‑of‑trend for Biopharmaceuticals: A Guide manufacturing, Lynn Torbeck
Sterilization definitions and proposes to Risk‑Based Validation and has created a “must read” for
terminology to clarify the use of the word Implementation Strategies anyone involved in product
EDITOR: Jeanne Moldenhauer
“control” in several contexts. Outtakes from FDA AUTHOR: Stephan Krause development, formulation, manufacturing, and
The various authors cited in quality. Each of the 45 chapters in this book
warning letters, plant audits, and investigations 2007. 174 pages. Digital: Item No. 17971
this book have a wealth of address a specific aspect of applied statistics
for trend and out-of-trend are presented to
practical experience in thermal
highlight the Agency’s viewpoint. 2015. 195 pages.
M $280 | NM $349 | G $200 and provides pragmatic applications to such
validation of moist heat topics as: Can we save the Technical
sterilization processes. This Digital: Item No. 18012 Conference?; %RSD friend, Foe or Faux?; OOS,
book is an essential reference
guide for managers,
M $210 | NM $259 | G $190 OOT, OOC and OOSC; and more. 2015. 435 pages.
Hardcover: Item No. 17333 | Digital: Item No. 18014
supervisors, and all others
concerned with preparing validation plans M $210 $168 | NM $259 $207 | G $190 $152
acceptable to regulators worldwide.
2011. 301 pages.
Digital: Item No. 17998
M $225 $180 | NM $279 $223 | G $180 $144

14 www.pda.org/bookstore 15
 PDA Booklets Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series

2020 PDA PUBLICATIONS CATALOG

Risk Management Library
PDACMYK
PMS
301
Booklets contain
C:100 M:45 Y:0 K:18
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one chapter from a larger publication, chosen for
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#335F9B The U.S. FDA now takes a risk-based approach to biomanufacturing. With high regulatory expectations
the relevance of content, expertise of the author, and industry demand. described in 21CFR 600 and other international regulations, these perspectives will enable you to
manage risks involved in safely producing healthcare products for patient consumption. Written by
Cleaning SOPs: Five Proven Pharmaceutical Manufacturing: subject matter experts, these convenient, electronic texts define risk, discuss hazards and risks,
and Validated SOPs Understanding Your Process Series provide tools to help you evaluate risk, and develop effective strategies for dealing with risk. 
AUTHOR: Anne Marie Over the past 15 years, PDA/DHI has published more than 1,000 Each text discusses your risk concerns and contains practical details and applications, includes
Dixon-Heathman practical scientific and regulatory chapters, written by global extensive lists of international regulations for reference, and suggests PDA Technical Reports and
Cleaning and sanitization is a subject matter experts. These informative collections have been PDA/DHI books for further guidance.
common 483 citing. The clean-
ing methods in these five SOPs
designed to help you stay abreast of new technology, streamline
have been proven and validated. your processes, and comply with regulations. Our newest Risk Management Library Risk Management Risk Management Library
They are based upon published compendium offers background information and hands-on Volume 1: Lifecycle Risk Library Volume 3: Volume 5, Risk Problem
information in US standards and applications in an electronic format on three vital topics: cleaning
ISO standards. Renowned global
Management Practical Approaches to Solvers: Failure to Follow
and cleanrooms, sterilization, and environmental monitoring. Risk Assessment and Established Procedures
expert, Anne Marie Dixon-Heath- EDITORS: Edwin Bills and Stan
man offers invaluable details that Mastrangelo Management EDITORS: Russell E. Madsen and
will assist you in reducing the Cleaning and Cleanrooms monitoring for sterility test
isolators, and how to present Written by experienced authors, AUTHOR: James L. Vesper Maik W. Jornitz
risk of surface contamination to EDITORS: Jeanne Moldenhauer this Volume offers insight into Sometimes even well-designed
environmental monitoring In this Volume, well-respected
processes and products. In and Tim Sandle the risk management processes, systems are thwarted by human
data to internal and external global experts give an overview
short, they work! This collection features a two- management considerations, behavior, causing a series of
stakeholders. 2017. 92 pages. of the risk management process
SOPs included are: part history of cleaning and and strategies in product devel- and the tools required, including blunders that common sense
cleanrooms, classifications, Digital: Item No. 18032 opment, implementation of risk

PDA BOOKLE TS
•C leaning and Disinfection of risk-related documents and says could not have happened.
supplies, sanitization, and management for non-product
Biosafety Hoods
several other important topics.
M $120 | NM $150 | G $120
software, and the future of risk
records and techniques for In this Volume, you’ll find 10
examples and solutions to
•C leaning and Disinfection of auditing a risk management
2017. 114 pages. management. 2018. 126 pages. program. 2018. 56 pages. problems arising from failure to
Laminar Flow Hoods
Sterilization: Establishing Digital: Item No. 18044 follow established procedures.
•C leaning and Disinfection of Digital: Item No. 18028 Digital: Item No. 18046
the Process 2018. 56 pages.
Aseptic Cleanrooms M $120 | NM $150 | G $120 M $100 | NM $125 | G $100 M $100 | NM $125 | G $100
• Cleaning and Disinfection ISO 7-8 AUTHOR: Tim Sandle Digital: Item No. 18048
• Cleaning and Sanitization - CNC.
Environmental Monitoring,
Navigate compliance aspects
of sterility testing, containment Risk Management Library
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Digital: Item No. 18057 Risk Management
Volume 1: Establishing the system sterility, and sterility test Volume 2: Practical Library Volume 4:
failure investigations. Approaches to Risk-Based Risk Management Library
M $240 | NM $299 | G $240 Process
2017. 193 pages Practical Approaches to
EDITOR: Jeanne Moldenhauer Compliance Risk Assessment and Volume 6, Risk Problem
Discover how to design and Digital: Item No. 18029 AUTHOR: Siegfried Schmitt Management Problem Solvers: Lack of Process
Biopharmaceutical Validation Understanding
and Technical Transfer
implement a control program,
monitor microbiology
M $120 | NM $150 | G $120 This Volume offers guidance in Solving: Tips and Case
implementing process analytical Studies EDITORS: Russell E. Madsen and
AUTHOR: Russell E. Madsen laboratories, and more. technology (PAT), discusses Maik W. Jornitz
NEWThis document discusses 2017. 175 pages. Sterilization: Practical the challenges and pitfalls of AUTHOR: Tim Sandle
This Volume discusses diagnosis
why and how to validate and Approaches applying a science and risk- Receive expert guidance on and corrective actions to common
Digital: Item No. 18031
transfer a process. It offers a based approach in research and major topics, such as regulatory problems, such as incorrect batch
AUTHOR: Tim Sandle
helpful example, includes M $120 | NM $150 | G $120 manufacturing, and presents perspectives on risk and five records, contaminated product
protocol details and discusses Explore practical approaches to documented evidence for insightful case studies to help
sterility testing, gamma irradia- complaints, contamination,
non-traditional process risk-based compliance. develop the best approaches to environmental monitoring, and
validation, life cycle Environmental Monitoring, tion for single-use disposables, 2018. 92 pages. problem solving based upon the many other subjects.
management, change Volume 2: Practical ophthalmic preparations, and “What if” and “five whys” method.
contamination control. Digital: Item No. 18045 2018. 102 pages.
management, and much more. Approaches 2017. 106 pages
2018. 150 pages.
2018. Digital: Item No. 18058 EDITOR: Jeanne Moldenhauer
M $100 | NM $125 | G $100
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M $120 | NM $150 | G $120 Learn about rapid microbiological
Digital: Item No. 18030
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monitoring, environmental M $120 | NM $150 | G $120

16 www.pda.org/bookstore 17
 Risk Management Library (continued) API Residues and Cleaning Best Practices in Implementing Quality Designing a Contamination Control

2020 PDA PUBLICATIONS CATALOG

AUTHOR: William Hall Agreements Program
RiskCMYK
ManagementRGBLibrary Volume Hex code for7,
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2013. 22 pages. AUTHOR: Kenneth Drost AUTHOR: Sandra Lowery
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#335F9B
Digital: Item No. 17954 2013. 22 pages. 2004. 67 pages.
Procedures and Process Contro
EDITORS: Russell E. Madsen and Maik W. Jornitz
M $55 | NM $69 | G $45 Digital: Item No. 17956 Digital: Item No. 17902

This Volume describes 24 problems and offers

M $55 | NM $69 | G $45 M $105 | NM $129 | G $45

solutions regarding everything from bioburden Application and Insights for Lyophilization
contamination in a contained water system to of Parenteral Products Caveats of Bacterial Endotoxin Testing Designing and Controlling Water Systems
filter integrity, customer complaints, process AUTHOR: Edward Trappler AUTHOR: Kevin Williams EDITORS: Russell Madsen and
control failures, and many more real-world Jeanne Moldenhauer
2009. 31 pages. 2007. 35 pages.
problems that were solved with adequate
Digital: Item No. 17932 Digital: Item No. 17938 2014. 145 pages.
investigations. 2018. 122 pages.
Digital: Item No. 18050
M $55 | NM $69 | G $30 M $55 | NM $69 | G $30 Digital: Item No. 17966
M $145 | NM $179 | G $110
M $100 | NM $125 | G $100
Aseptic Process Validation and Cleaning Agents and Cleaning Chemistry
Aseptic Process Simulation Studies AUTHORS: Nancy Kaiser and George Verghese Environmental Impact on Media Fills
AUTHOR: Harold Baseman 2009. 22 pages. AUTHOR: John Lindsay
2009. 31 pages. Digital: Item No. 17957 2005. 36 pages.
Digital: Item No. 17934 M $55 | NM $69 | G $45 Digital: Item No. 17914
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PDA BOOKLE TS
Cleaning and Disinfection
Auditing the CMO EDITORS: Russell Madsen and Jeanne Implementing Process Analytical
AUTHORS: Thomas Thorpe and Jessica Walker Moldenhauer Technology: The Challenges and Pitfalls
2013. 28 pages. 2014. 150 pages. of Applying a Science and Risk‑Based
Approach in Research and Manufacturing
Digital: Item No. 17955 Digital: Item No. 17969
AUTHORS: Siegfried Schmitt and
M $55 | NM $69 | G $45 M $145 | NM $179 | G $110
Jennifer Thompson
2008. 15 pages.
Best Practices in Environmental CMOs for Early Phase Biologicals Digital: Item No. 17935
Monitoring Automation Production: Contract Manufacturing and
Control
M $35 | NM $45 | G $25
AUTHORS: Robert Toal, Michael Goetter, Susan
Harrison, Jeremy Tanner, Timothy A. Coleman, AUTHORS: John Conner, Bill Minshall, and
and Robert Lutskus Rabi Prusti Microbiological Validation Master Plan
2009. 21 pages. 2013. 53 pages. AUTHOR: Trevor Deeks
Digital: Item No. 17941 Digital: Item No. 17958 2004. 42 pages.
M $55 | NM $69 | G $30 M $55 | NM $69 | G $45 Digital: Item No. 17904
M $75 | NM $89 | G $35

Contamination Risk Assessment

EDITORS: Russell Madsen and
Jeanne Moldenhauer
2014. 210 pages.
Digital: Item No. 17968
M $145 | NM $179 | G $110

18 www.pda.org/bookstore 19
 Mold and Fungal Contamination QbD and Process Validation — Training and Learning Critical Contributors Validation of Rapid Methods and Systems

2020 PDA PUBLICATIONS CATALOG

EDITORS: Russell Madsen and Complementary Lifecycle Approaches to Quality and Validation of Sterility Test Suites and
Jeanne
PMS CMYK
MoldenhauerRGB Hex code for Web
AUTHOR: Paul Pluta AUTHOR: James L. Vesper Isolators
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
2014. 110 pages. 2011. 50 pages. 2006. 34 pages. AUTHOR: Jeanne Moldenhauer
Digital: Item No. 17967 Digital: Item No. 17961 Digital: Item No. 17906 2004. 33 pages.
M $145 | NM $179 | G $110 M $55 | NM $69 | G $45 M $55 | NM $69 | G $30 Digital: Item No. 17901
M $55 | NM $69 | G $30

Particulate Matter in Injectable Drug Regulatory Background to Aseptic Training of Aseptic Processing Personnel
Products Processing AUTHOR: James L. Vesper Validation of Sterilization Processes
AUTHOR: Stephen Langille AUTHORS: Gordon Farquharson and 2008. 27 pages. AUTHOR: James Agalloco
2014. 37 pages. Richard Johnson Digital: Item No. 17936 2004. 51 pages.
2009. 16 pages.
Digital: Item No. 17965 M $55 | NM $69 | G $30 Digital: Item No. 17907
M $55 | NM $69 | G $45 Digital: Item No. 17931 M $75 | NM $89 | G $35
M $35 | NM $45 | G $25
Using Statistics to Measure and Improve
Pharmaceutical Microbiology Laboratories Quality Validation Procedures for the Bacterial
Proficiency and Competency Risk Management for Combination AUTHOR: Lynn Torbeck Endotoxins Test
AUTHOR: Jerry Tjernagel Products 2006. 42 pages. AUTHORS: James Cooper and Cheryl Moses
2009. 12 pages. AUTHOR: Edwin Bills Digital: Item No. 17912 2004. 28 pages.
2013. 38 pages.
Digital: Item No. 17940 M $75 | NM $89 | G $35 Digital: Item No. 17908

PDA BOOKLE TS
M $35 | NM $45 | G $25 Digital: Item No. 17962 M $55 | NM $69 | G $30
M $55 | NM $69 | G $45
Validation of Environmental Monitoring
Practical Aspects of Thermal Validation Methods
for Moist Heat Sterilization Sources and Control of Contamination AUTHOR: Dawn Mclver
AUTHORS: Angela Coon and Michael Sadowski EDITORS: Russell Madsen and 2004. 23 pages.
2011. 58 pages. Jeanne Moldenhauer Digital: Item No. 17913
2014. 250 pages.
Digital: Item No. 17949 M $55 | NM $69 | G $30
M $85 | NM $105 | G $45 Digital: Item No. 17970
M $200 | NM $250 | G $150
Validation of Microbial Identification
Practical Things to Improve Aseptic Systems
Process Equipment System Operation, Steam Sterilization Process Validation AUTHOR: Jeanne Moldenhauer
Reduce Interventions and Reduce AUTHOR: James Agalloco 2004. 86 pages.
Product Risk 2011. 42 pages. Digital: Item No. 17909
AUTHOR: Jack Lysfjord
2010. 14 pages.
Digital: Item No. 17950 M $130 | NM $159 | G $55
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Digital: Item No. 17933
M $35 | NM $45 | G $25

20 www.pda.org/bookstore 21
 PDA Technical Reports

2020 PDA PUBLICATIONS CATALOG

NEW PDA Technical Report No. 83 (TR 83) Top 5 Best Sellers
Virus Contamination in Biomanufacturing: PDA Technical Report No. 80 (TR 80)
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peer-reviewed global consensus documents written by
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Risk Mitigation, Preparedness, and
subject matter experts on a wide variety of industry-related topics. They offer expert Data Integrity Management System for
Response Pharmaceutical Laboratories
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This Technical Report,
as essential references by industry and regulatory authorities around the world. Report is to describe the
developed by subject matter
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PDA Technical Report No. 54-6
NEW NEW PDA Technical Report No. 81 (TR 81) necessary to establish a robust
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(TR 54-6) Formalized Risk Assessment Cell-Based Therapy Control Strategy data integrity management
response should such an event occur in
for Excipients This Technical Report focuses on system to ensure data integrity for paper, hybrid,
manufacturing processes using in vitro
PDA Technical Report No. 54-6, the development of a risk-based mammalian or other eukaryotic cell cultures to and computerized systems within the
Formalized Risk Assessment control strategy adapted to produce biopharmaceutical products. laboratory. It is intended to outline regulatory
for Excipients, is the sixth cell-based therapy that can 2019. 40 pages.
requirements and expectations, along with
technical report (TR) in the TR mitigate the risk of generating best industry practices, to ensure data integrity,
54 series related to various a product of poor quality. Digital: Item No. 43541 to highlight common gaps in laboratory data
aspects of Quality Risk 2019. 58 pages. M $180 | NM $325 | G $180 management practices, and to recommend
Management (QRM). It was methods of remediation. 2018. 63 pages.
Digital: Item No. 43538 Softcover: Item No. 01083
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assessment for ascertaining the appropriate M $250 | NM $375 | G $250 NEW PDA Reporte Tecnico No. 13 M $250 | NM $375 | G $250
GMP for excipients of medicinal products for Revisado (TR 13) Fundamentos de un
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NEW PDA Technical Report No. 82 (TR 82) Español (versión digital de un solo PDA Technical Report No. 26 (TR 26)
publication of the same name. The information
in TR 54-6 applies to all excipients used in drug Low Endotoxin Recovery usuario) Revised 2008, Sterilizing Filtration
products for human use at all stages of the This Technical Report aims to This Technical Report is of Liquids
product lifecycle. 2019. 45 pages. describe the underlying now available in Spanish in PDA’s original Technical
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factors of LER, summarize the 2014. 39 pages. 1998, described the use and
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within the pharmaceutical industry. References
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to scientific publications and international
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2008. 62 pages.
Digital: Item No. 43230
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22 www.pda.org/bookstore 23
 PDA Technical Reports PDA BOOKSTORE

PDA Technical Report No. 13 Revised PDA Technical Report No. 60 (TR 60) Price is for each Digital: $180 | $325 | $180 Softcover: $250 | $375 | $250

2020 PDA PUBLICATIONS CATALOG

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(TR 13) Fundamentals of an Process Validation: A Lifecycle Approach technical report.
PMSEnvironmental
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PDA Technical Report No. 13 Validation: A Lifecycle Ap-
(Revised): Fundamentals of an proach presents timely and PDA Technical Report No. 54-6 (TR 54-6) Formalized PDA Technical Report No. 76 (TR 76) Identification
Environmental Monitoring real world guidance for the Risk Assessment for Excipients 2019. 45 pages. and Classification of Visible Nonconformities in
Program serves as a resource application of a lifecycle Digital: Item No. 43542 | Softcover: Item No. 01054-6 Elastomeric Components and Aluminum Seals for
on controlled environmental approach to process valida- Parenteral Packaging 2016. 59 pages.
test methods and, although tion. The lifecycle approach PDA Technical Report No. 83 (TR 83) Virus Digital: Item No. 43529 | Softcover: Item No. 01076
some nonviable particulate has been the focus of recent Contamination in Biomanufacturing: Risk Mitigation,
information is included, the process validation guidance from major Preparedness, and Response 2019. 40 pages. PDA Technical Report No. 75 (TR 75) Consensus
report’s primary focus is microbiological control regulatory agencies and represents a signifi- Digital: Item No. 43541 | Softcover: Item No. 01083 Method for Rating 0.1µm Mycoplasma Reduction
for sterile product manufacturing. 2014. 39 pages. cant change in expectations in this area. This Filters 2016. 22 pages.
PDA Technical Report No. 82 (TR 82) Low Endotoxin Digital: Item No. 43528 | Softcover: Item No. 01075
Digital: Item No. 43513 technical report, part of the PCMOsm initiative,
Recovery 2019. 128 pages.
will review requirements for process validation
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studies across the three-stage approach
Digital: Item No. 43539 | Softcover: Item No. 01082 PDA Technical Report No. 74 (TR 74) Reprocessing
of Biopharmaceuticals 2016. 33 pages.
Softcover: Item No. 01013 defined by FDA and also discuss best practices PDA Technical Report No. 81 (TR 81) Cell-Based Digital: Item No. 43526 | Softcover: Item No. 01074
for integration with supporting Quality Systems.
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2013. 102 pages.
Therapy Control Strategy 2019. 58 pages.
Digital: Item No. 43538 | Softcover: Item No. 01081 PDA Technical Report No. 56 Revised 2016 (TR 56)
Digital: Item No. 43502 Application of Phase‑Appropriate Quality System and
PDA Technical Report No. 80 (TR 80) Data
PDA Technical Report No. 79 (TR 79) M $180 | NM $325 | G $180
Integrity Management System for Pharmaceutical
cGMP to the Development of Therapeutic Protein
Drug Substance (API or Biological Active Substance)

TECHNICAL REPORTS
Particulate Matter Control in Difficult to Softcover: Item No. 01060 Laboratories 2018. 63 pages. 2016. 36 pages.
Inspect Parenterals Digital: Item No. 43537 | Softcover: Item No. 01080
M $250 | NM $375 | G $250 Digital: Item No. 43530 | Softcover: Item No. 01056
This Technical Report
PDA Technical Report No. 79 (TR 79) Particulate PDA Technical Report No. 73 (TR 73) Prefilled
describes best practices for
Matter Control in Difficult to Inspect Parenterals Syringe User Requirements for Biotechnology
difficult to inspect (DIP)
Bundle of PDA Technical Reports 2018. 36 pages. Applications 2015. 117 pages.
product lifecycle management,
PDA Technical Series: Sterilization Digital: Item No. 43536 | Softcover: Item No. 01079 Digital: Item No. 43525 | Softcover: Item No. 01073
destructive testing and
trending to supplement Compilation of Technical Reports and
PDA Technical Report No. 78 (TR 78) Particulate PDA Technical Report No. 72 (TR 72) Passive
portions of the guidance given Journal Articles on Pharmaceutical
Matter in Oral Dosage Forms 2017. 30 pages. Thermal Protection Systems for Global Distribution:
in USP General Chapter Sterilization
Digital: Item No. 43535 | Softcover: Item No. 01078 Qualification and Operational Guid ance
<1790>: Visible Particulates in Injection. It is This volume is a convenient
2015. 64 pages.
intended to provide logical pathways to DIP and powerful reference for PDA Technical Report No. 77 (TR 77) The
Digital: Item No. 43524 | Softcover: Item No. 01072
product inspection and testing to support individuals working with Manufacture of Sterile Pharmaceutical Products
continual process improvement in the industry. sterilization processes for Using Blow‑Fill‑Seal Technology 2017. 40 pages. PDA Technical Report No. 71 (TR 71) Emerging
2018. 36 pages. pharmaceutical products. Digital: Item No. 43531 | Softcover: Item No. 01077 Methods for Virus Detection 2015. 52 pages.
Digital: Item No. 43536 2014. 424 pages. Digital: Item No. 43523 | Softcover: Item No. 01071
PDA Technical Report No. 60‑2 (TR 60‑2) Process
M $180 | NM $325 | G $180
Validation: A Lifecycle Approach, Annex 1: Oral Solid PDA Technical Report No. 70 (TR 70) Fundamentals
Softcover: Item No. 01079 Dosage/Semisolid Dosage Forms 2017. 40 pages. of Cleaning and Disinfection Programs for Aseptic
Digital: Item No. 43512 Digital: Item No. 43532 | Softcover: Item No. 01060‑2
M $250 | NM $375 | G $250 Manufacturing Facilities 2015. 75 pages.
M $500 | NM $940 | G $300
PDA Technical Report No. 54‑5 (TR 54‑5) Quality
Digital: Item No. 43522 | Softcover: Item No. 01070

Risk Management for the Design, Qualification, PDA Technical Report No. 69 (TR 69) Bioburden
and Operation of Manufacturing Systems and Biofilm Management in Pharmaceutical
Customized Institutional Site Licensing of PDA Technical Reports is Now Available. 2017. 107 pages. Manufacturing Operations 2015. 73 pages.
To learn more, please contact: Janny Chua, Bookstore Operations Manager Digital: Item No. 43533 | Softcover: Item No. 01054‑5 Digital: Item No. 43521 | Softcover: Item No. 01069
Telephone: +1 (301) 656-5900, ext. 133 Email: [email protected]

24 www.pda.org/bookstore 25
 PDA Technical Reports PDA BOOKSTORE

PDA Technical Report No. 57‑2, (TR 57‑2) Analytical PDA Technical Report No. 60 (TR 60) Process PDA Technical Report No. 55 (TR 55) Detection and PDA Technical Report No. 48 (TR 48) Moist Heat

2020 PDA PUBLICATIONS CATALOG

Method Development and Qualification for Validation: A Lifecycle Approach 2013. 102 pages. Mitigation of 2,4,6‑Tribromoanisole and 2,4,6‑Trichlo- Sterilizer Systems: Design, Commissioning,
PMSBiotechnology
CMYK Products
RGB 2015. 59 Hexpages.
code for Web Digital: Item No. 43502 | Softcover: Item No. 01060 roanisole Taints and Odors in the Pharmaceutical and Operation, Qualification and Maintenance
301
Digital: Item No. 43519
C:100 M:45 Y:0 K:18
| Softcover:#335F9B
R:51 G:95 B:155
Item No. 01057‑2 Consumer Healthcare Industries 2012. 91 pages. 2010. 64 pages.
PDA Technical Report No. 54‑3 (TR 54‑3) Digital: Item No. 43494 | Softcover: Item No. 01055 Digital: Item No. 43487 | Softcover: Item No. 01048
PDA Technical Report No. 54‑4, (TR 54‑4) Implementation of Quality Risk Management for
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing PDA Technical Report No. 54 (TR 54) Implementation PDA Technical Report No. 47 (TR 47) Preparation of
Pharmaceutical and Biotechnology Manufacturing Operations: Annex 2: Case Studies in the of Quality Risk Management for Pharmaceutical and Virus Spikes Used for Virus Clearance Studies
Operations: Annex 3: Case Studies in the Manufacturing of Pharmaceutical Drug Products Biotechnology Manufacturing Operations 2010. 64 pages.
Manufacturing of Biotechnological Bulk Drug 2013. 53 pages. 2012. 61 pages. Digital: Item No. 43486 | Softcover: Item No. 01047
Substances 2015. 82 pages. Digital: Item No. 43511 | Softcover: Item No. 01054‑3 Digital: Item No. 43493 | Softcover: Item No. 01054
Digital: Item No. 43518 | Softcover: Item No. 01054‑4 PDA Technical Report No. 46 (TR 46) Last Mile:
PDA Technical Report No. 54‑2 (TR 54‑2) PDA Technical Report No. 30 Revised 2012, (TR 30) Guidance for Good Distribution Practices for
PDA Technical Report No. 67, (TR 67) Exclusion Implementation of Quality Risk Management for Parametric Release of Pharmaceuticals and Medical Pharmaceutical Products to the End User
of Objectionable Microorganisms from Nonsterile Pharmaceutical & Biotechnology Manufacturing Device Products Terminally Sterilized by Moist Heat 2009. 38 pages.
Pharmaceuticals, Medical Devices, and Cosmetics Operation: Annex 1: Case Study Examples for Quality 2012. 34 pages. Digital: Item No. 43485 | Softcover: Item No. 01046
2014. 70 pages. Risk Management in Packaging & Labeling Digital: Item No. 43234 | Softcover: Item No. 01030
Digital: Item No. 43516 | Softcover: Item No. 01067 2013. 63 pages. PDA Technical Report No. 15, Revised 2009 (TR 15)
Digital: Item No. 43504 | Softcover: Item No. 01054‑2 PDA Technical Report No. 29, Revised 2012 (TR 29) Validation of Tangential Flow Filtration in
PDA Technical Report No. 66, (TR 66) Application Points to Consider for Cleaning Validation Biopharmaceutical Applications 2009. 52 pages.
of Single‑Use Systems in Pharmaceutical PDA Technical Report No. 43, Revised 2013 (TR 43) 2012. 105 pages. Digital: Item No. 43221 | Softcover: Item No. 01015
Manufacturing 2014. 152 pages. Identification and Classification of Nonconformities Digital: Item No. 43501 | Softcover: Item No. 01029
Digital: Item No. 43515 | Softcover: Item No. 01066 in Molded and Tubular Glass Containers for PDA Technical Report No. 45, (TR 45) Filtration of

TECHNICAL REPORTS
Pharmaceutical Manufacturing 2013. 190 pages. PDA Technical Report No. 53 (TR 53) Guidance for Liquids Using Cellulose‑Based Depth Filters
PDA Technical Report No. 65, (TR 65) Technology Digital: Item No. 43508 | Softcover: Item No. 01043 Industry: Stability Testing to Support Distribution of 2008. 38 pages.
Transfer 2014. 67 pages. New Drug Products 2011. 29 pages. Digital: Item No. 43422 | Softcover: Item No. 01045
Digital: Item No. 43514 | Softcover: Item No. 01065 PDA Technical Report No. 33, Revised 2013 (TR Digital: Item No. 43492 | Softcover: Item No. 01053
33) Evaluation, Validation and Implementation of PDA Technical Report No. 44, (TR 44) Quality Risk
PDA Technical Report No. 13 Revised, (TR 13) Alternative and Rapid Microbiological Methods PDA Technical Report No. 52 (TR 52) Guidance Management for Aseptic Processes 2008. 42 pages.
Fundamentals of an Environmental Monitoring 2013. 59 pages. for Good Distribution Practices (GDPs) For the Digital: Item No. 43410 | Softcover: Item No. 01044
Program 2014. 39 pages. Digital: Item No. 43510 | Softcover: Item No. 01033 Pharmaceutical Supply Chain 2011. 36 pages.
Digital: Item No. 43513 | Softcover: Item No. 01013 Digital: Item No. 43491 | Softcover: Item No. 01052 PDA Technical Report No. 41, Revised 2008 (TR 41)
PDA Technical Report No. 3, Revised 2013 (TR 3) Virus Filtration 2008. 62 pages.
PDA Technical Report No. 64 (TR 64) Active Validation of Dry Heat Processes Used for PDA Technical Report No. 22, (TR 22) Revised 2011 Digital: Item No. 43313 | Softcover: Item No. 01041
Temperature‑Controlled Systems: Qualification Depyrogenation and Sterilization 2013. 40 pages. Process Simulation for Aseptically Filled Products
Guidance 2013. 58 pages. 2011. 50 pages. Digital: Item No. 43226 PDA Technical Report No. 26, (TR 26) Revised 2008,
Digital: Item No. 43506 | Softcover: Item No. 01003
Digital: Item No. 43509 | Softcover: Item No. 01064 Sterilizing Filtration of Liquids 2008. 62 pages.
PDA Technical Report No. 59 (TR 59) Utilization of PDA Technical Report No. 51 (TR 51) Biological Digital: Item No. 43230
PDA Technical Report No. 63 (TR 63) Quality Statistical Methods for Production Monitoring Indicators for Gas and Vapor‑Phase Decontamination
Requirements for the Extemporaneous Preparation of Processes: Specification, Manufacture, Control PDA Technical Report No. 14, (TR 14) Validation of
2012. 74 pages.
Clinical Trial Materials 2013. 27 pages. and Use 2010. 42 pages. Column‑Based Chromatography Processes for the
Digital: Item No. 43500 | Softcover: Item No. 01059
Digital: Item No. 43507 | Softcover: Item No. 01063 Digital: Item No. 43490 | Softcover: Item No. 01051 Purification of Proteins 2008. 38 pages.
PDA Technical Report No. 58 (TR 58) Risk Digital: Item No. 43220 | Softcover: Item No. 01014
PDA Technical Report No. 62 (TR 62) Recommended Management for Temperature‑Controlled Distribution PDA Technical Report No. 50 (TR 50) Alternative
Practices for Manual Aseptic Processes Methods for Mycoplasma Testing 2010. 52 pages. PDA Technical Report No. 1, Revised 2007, (TR 1)
2012. 73 pages.
2013. 30 pages. Digital: Item No. 43489 | Softcover: Item No. 01050 Validation of Moist Heat Sterilization Processes
Digital: Item No. 43499 | Softcover: Item No. 01058
Digital: Item No. 43505 | Softcover: Item No. 01062 Cycle Design, Development, Qualification and
PDA Technical Report No. 57 (TR 57) Analytical PDA Technical Report No. 49 (TR 49) Points to Ongoing Control 2007. 54 pages.
PDA Technical Report No. 61 (TR 61) Steam In Place Method Validation and Transfer for Biotechnology Consider for Biotechnology Cleaning Validation Digital: Item No. 43381 | Softcover: Item No. 01001
2013. 61 pages. Products 2012. 74 pages. 2010. 76 pages.
Digital: Item No. 43503 | Softcover: Item No. 01061 Digital: Item No. 43497 | Softcover: Item No. 01057 Digital: Item No. 43488 | Softcover: Item No. 01049

26 www.pda.org/bookstore 27
 PDA Technical Reports PDA BOOKSTORE

PDA Technical Reports (older ones) Price is for each technical report. $50 | $100 | $50

2020 PDA PUBLICATIONS CATALOG

M NM G

The price is the same for digital and softcover items.

PMS CMYK RGB Hex code for Web
301 C:100 M:45 Y:0 K:18 R:51 G:95 B:155 #335F9B
PDA Technical Report No. 39, Revised 2007, (TR 39) PDA Technical Report No. 27, (TR 27) The below Technical Report is free of charge and available to everyone.
Guidance for Temperature‑Controlled Medicinal Pharmaceutical Package Integrity 1998. 48 pages. PDA Technical Report No. 68, (TR 68) Risk Based Approach for Prevention and
Products: Maintaining the Quality of Digital: Item No. 43231 Management of Drug Shortages 2014. 54 pages. Digital: Item No. 43517
Temperature‑Sensitive Medicinal Products Through
the Transportation Environment 2007. 20 pages. PDA Technical Report No. 16, (TR 16) Effect of
Gamma Irradiation on Elastomeric Closures
PDA Points to Consider Documents
Digital: Item No. 43312 | Softcover: Item No. 01039
1992. 13 pages. Points to Consider for Aging Facilities PDA’s Points to Consider for Aging Facilities takes into account the
PDA Technical Report No. 38, (TR 38) Manufacturing Digital: Item No. 43222 pharmaceutical manufacturing industry’s general thoughts and suggestions on how to identify and modernize
Chromatography Systems Postapproval Changes aging facilities. 2017. 31 pages.
(ChromPAC): Chemistry, Manufacturing and Controls PDA Technical Report No. 20, (TR 20) Report on
Documentation 2006. 30 pages. Survey of Current Industry Gowning Practices
Digital: Item No. 43534 M $180 | NM $325 | G $180 Softcover: Item No. 03008 M $250 | NM $375 | G $250

Digital: Item No. 43315 | Softcover: Item No. 01038 1990. 5 pages. Points to Consider for Aseptic Processing: Part 2, May 2016 2016. 58 pages.
Digital: Item No. 41239
PDA Technical Report No. 28 Revised, (TR 28) Digital: Item No. 43527 M $180 | NM $325 | G $180 Softcover: Item No. 03007 M $250 | NM $375 | G $250
Process Simulation Testing for Sterile Bulk PDA Technical Report No. 19, (TR 19) Rapid/
Pharmaceutical Chemicals 2006. 24 pages. Automated ID Methods Survey 1990. 7 pages. Points to Consider for Aseptic Processing: Part 1, January 2015 2015. 65 pages.
Digital: Item No. 43232 | Softcover: Item No. 01028 Digital: Item No. 43225 Digital: Item No. 43520 M $180 | NM $325 | G $180 Softcover: Item No. 03005 M $250 | NM $375 | G $250

PDA Technical Report No. 42, (TR 42) Process PDA Technical Report No. 12, (TR 12) Siliconization
Points to Consider for Aseptic Processing ‑ PDA Journal of Pharmaceutical Science and Technology:
Validation of Protein Manufacturing 2005. 28 pages. of Parenteral Drug Packaging Components

TECHNICAL REPORTS
2003 Supplement Volume 57 Issue 2 2003. 72 pages.
Digital: Item No. 43311 | Softcover: Item No. 01042 1988. 14 pages.
Digital: Item No. 43217 | Softcover: Item No. 01012 Digital: Item No. 42148 | Softcover: Item No. 03004 M $50 | NM $100 | G $50
PDA Technical Report No. 40, (TR 40) Sterilizing
Filtration of Gases 2005. 44 pages. PDA Technical Report No. 11, (TR 11) Sterilization
Digital: Item No. 43314 | Softcover: Item No. 01040 of Parenterals by Gamma Radiation 1988. 9 pages.
Digital: Item No. 43216
PDA Technical Report No. 35, (TR 35) A Proposed
Training Model for the Microbiological Function in PDA Technical Report No. 10, (TR 10) Parenteral
the Pharmaceutical Industry 2001. 24 pages. Formulations of Proteins and Peptides: Stability and
Digital: Item No. 43240 Stabilizers 1988. 26 pages.
Digital: Item No. 43215
PDA Technical Report No. 34, (TR 34) Design and
Validation of Isolator Systems for the Manufacturing PDA Technical Report No. 5, (TR 5) Sterile
and Testing of Health Care Products 2001. 25 pages. Pharmaceutical Packaging: Compatibility and
Digital: Item No. 43239 | Softcover: Item No. 01034 Stability 1984. 137 pages.
Digital: Item No. 43210
PDA Technical Report No. 31, (TR 31) Validation and
Qualification of Computerized Laboratory Data
Acquisition Systems 1999. 12 pages.
Digital: Item No. 43235 | Softcover: Item No. 01031

28 www.pda.org/bookstore 29
 PDA Surveys

PDA Research: 2019 Sterile Lyophilized PDA Survey: 2017 PDA PUPSIT Survey PDA Survey: 2015 Aging Facilities PDA Survey: 2014 Visual Inspection

2020 PDA PUBLICATIONS CATALOG

Drug Product Loading Survey In March 2017, PDA conducted This survey clarifies the mean- In August of 2014, the fourth in
PMS CMYK ThisRGBsurvey is designed to align
Hex code for Web a benchmarking survey to ing of an aging facility, process, a series of surveys was
301 C:100 M:45 Y:0 K:18
andR:51
expand PDA’s
G:95 B:155
insight on
#335F9B
better understand the current and analytics and explores the launched by PDA to better
current practices for companies situation regarding sterile types and effectiveness of understand and document
that manufacture sterile filtration and the preventative measures. The current industry practices in this
lyophilized drug products and implementation of Pre-Use Post survey also identifies the important area. Past PDA Visual
conduct lyophilizer loading. It Sterilization Integrity Test, or obstacles encountered when Inspection surveys in 1996,
also provides insight into how PUPSIT, among large improvements are made and 2003, and 2008 have provided
today’s lyophilizer loading area pharmaceutical companies. Due to increased what actions should be taken to overcome practical guidance and insight to those working
operations can be improved to reduce enforcement of section 113 of Annex 1 by potential obstacles. 2016. 32 pages. in this field. The purpose of this survey was to
contamination from personnel. Each of the 91 European regulatory agencies, manufacturers Digital: Item No. 45009
document current industry practice for visual
respondents is involved in lyophilizer activities of sterile medical products are finding they inspection of injectable products. 2015. 22 pages.
within their current companies and possess an must modify their manufacturing processes to M $150 | NM $250 | G $150
Digital: Item No. 45006
understanding of their companies’ procedures incorporate the PUPSIT and/or are not able to
and needs. 2019. 26 pages. justify its exclusion on risk-based principles. PDA Survey: 2015 Particulate Matter in
M $150 | NM $250 | G $150

Digital: Item No. 45014 The survey was open to PDA members with Difficult to Inspect Parenterals
subject-matter expertise in PUPSIT and who
M $180 | NM $325 | G $180
hold the manager level position in biologic
This survey summarizes current PDA Survey: 2014 Quality Culture Metrics
practices in the inspection and This publication presents the
process development, manufacturing, control of particles in DIP results of the PDA Quality Culture
PDA Research: 2019 Technology Transfer validation, and/or quality. Readers are products and packaging Metrics Surveys conducted in
Industry Survey encouraged to draw his/her own conclusions materials. Findings include September and October 2014.

PDA SURVEYS
PDA has just released the 2019 from the presented summarized data and aspects of current processes in The objectives of these surveys
Technology Transfer Industry responses. 2018. 24 pages. manual, semi‑automated, and were to understand the maturity
Survey, designed to investigate Digital: Item No. 45011 automated inspection, along of quality culture in industry at
current practices and learn how with sampling plans and acceptable quantity the time and to identify
companies conduct technology
M $150 | NM $325 | G $150
limits used. 2016. 77 pages. appropriate attributes of quality culture that can
transfers, including their be measured. 2015. 39 pages.
Digital: Item No. 45008
technology transfer processes,
PDA Research: 2017 PDA Aseptic Digital: Item No. 45005
knowledge and risk manage-
Processing Survey
M $150 | NM $250 | G $150
ment systems, documentation, and business
This survey explores aseptic
M $150 | NM $250 | G $150
strategies. 2019. 26 pages.
processing practices for global PDA Survey: 2015 Particulate Matter in
Digital: Item No. 45013 secondary manufacturing Oral Dosage Forms PDA Survey: 2014 PDA Process Validation
M $180 | NM $325 | G $180 (finished product filling/ This survey documents current Survey
packaging), while taking into practices used by drug product This benchmarking survey was
consideration the changes and manufacturers, active designed to solicit feedback on
PDA Research: 2017 PDA Glass Quality needs of the modern, global, pharmaceutical ingredients and evaluate industry status of
Survey sterile, healthcare product manufacturers, excipient the application of the principles
This survey is designed to manufacturing industry. manufacturers, packaging/ established in the FDA Process
assist in the identification of
Digital: Item No. 45010 primary container Validation Guidance for
glass container quality concerns
manufacturers, and Industry of 2011.
and development of solutions to M $150 | NM $325 | G $150
consultants/regulators to control, inspect, 2014. 27 pages.
overcoming them. Survey topics
sample, and test particulate matter, intrinsic and Digital: Item No. 45004
include glass sampling and
extrinsic in oral dosage forms. 2016. 93 pages.
inspection practices, product
Digital: Item No. 45007
M $150 | NM $250 | G $150
complaints and recalls due to
glass defects, and quality oversight. M $150 | NM $250 | G $150
Digital: Item No. 45012
M $150 | NM $325 | G $150

30 www.pda.org/bookstore 31
 The PDA Journal
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