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PDA BookstoreToday’s Leading Bio/Pharmaceutical

Publications and Resources for Your Professional Library

https://store.pda.org/ProductCatalog/Product.aspx?ID=1744




Connecting People, Science and Regulation®

2 www.pda.org/bookstore

Dear Customer,

The Parenteral Drug Association (PDA) publishes an

extensive array of bio/pharmaceutical publications

and technical guides that provide you with the latest

scientific and regulatory information in our industry.

The PDA Bookstore is home to over 894 publications,

offered in both traditional and online formats. We

invite you to explore our inventory of recently and

forthcoming publications online (www.pda.org/bookstore)

and in this brochure.

I am pleased to announce our new Technical Report

Portal, which can be accessed by current PDA Standard

and Government members and will allow members

to view all PDA Technical Reports. I encourage you to

explore our collection and discover how TRs can assist

you and your company. Please visit www.pda.org for

more information.

We look forward to providing you with quality resources.

Sincerely,

Richard Johnson

President, PDA

www.pda.org/bookstore 3

PDA Bookstore

Table of Contents PDA Technical Books Pages 4-6

PDA Technical Reports & Resources Pages 7-13

Technical Report Portal Page 9

How to Order Page 13

Multimedia Training Tools Pages 14

The PDA Journal Page 15

About PDAThe 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 more than 9,500 members worldwide. To learn more about our community, please visit www.pda.org.

http://www.pda.org/bookstore

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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

PDA Technical BooksPDA Technical Books are scientific and regulatory guides 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

NOw AvAilABle

Encyclopedia of Rapid Microbiological Methods, Volume IVEditor: Michael Miller

Pharmaceutical microbiologists would be well served by considering which of their samples would provide a

benefit with a more rapid result and then assessing the current alternate microbiological methods to see if any of them are a good fit for their needs. The Encyclopedia of Rapid Microbiological Methods is an excellent resource to start that assessment.

Environmental Monitoring: A Comprehensive Handbook, Volume I, II, III, IV, V, VI and Protocol CD Editor: Jeanne Moldenhauer

These six volumes, with 112 chapters written by subject matter experts worldwide, describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume is different insofar as each speaks about different environmental monitoring issues. Numerous useful protocols are included on CD.

Save 20% on your entire purchase price when you buy the entire six volume set and protocol CD!

Bundle of Volume 1, 2, 3, 4, 5, 6 and protocol CD. 2012. Item No. 17305 Member: $1,630 / Nonmember: $2,030 / Government: $1,190

Available for Individual Purchase:Volume I 2005. Hardcover 455 pages. (Item No. 17211)Volume II 2005. Hardcover 459 pages. (Item No. 17237)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





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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 / Non-Member: $309 / Government: $200

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.


The Bacterial Endotoxins Test: A Practical Guide Editor: Karen McCullough

This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical

and compliant approach to the execution and use of bacterial endotoxins test.


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.


Validating Enterprise Systems: A Practical Guide Author: David Stokes

This book describes the latest tools, techniques and regulatory information needed to validate enterprise systems.


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.
















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 / Non-Member: $465 / Government: $250

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.


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.


Cleaning and Cleaning Validation, Volume 1 Editor: Paul Pluta

Volume one in this series, “Basics, Expectations, and Principles,” provides general information applicable to the entirety of cleaning and cleaning validation. This

includes process validation basics and expectations, including cleaning validation basics, regulatory guidelines and industry standards.


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 / Non-Member: $530 / Government: $290

Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 1 and 2 Author: Destin LeBlanc

The two volumes of Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contain a complete, modified and updated collection of LeBlanc’s Cleaning Memos.

Volume 1 originally published from 2000-2004 and Volume 2 published from January 2005 through December 2008. Hardcover. Item No. 17290

Member: $425 / Non-Member: $530 / Government: $290













PDA Bookstore


PDA Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach

PDA’s newest technical report, part of PDA’s Paradigm Change in Manufacturing OperationsSM initiative, presents timely and real

world guidance for the application of a lifecycle approach to process validation. The information found within this technical report will enable manufacturers to implement globally-compliant process validation programs.

Available in digital version only 2012. Item No. 43501 Member: $150 / Nonmember: $250 / Government: $75

PDA Technical Report No. 29, Revised 2012, (TR 29) Points to Consider for Cleaning Validation

This revised technical report presents updated information that is aligned with lifecycle approaches to validation and

the International Conference on Harmonisation (ICH) guidelines Q8 (R2) – Pharmaceutical Development, Q9 – Quality Risk Management, and Q10 – Pharmaceutical Quality System.

Available in digital version only Item No. 43502 Member: $150 / Nonmember: $250 / Government: $75

PDA Technical Report Distribution Series

PDA has organized the five most relevant technical reports about the supply chain distribution, covering testing to the last mile, in a convenient series. This

compilation is sure to be an invaluable guide for you as you navigate the scientific and regulatory aspects of supply chain distribution. The series includes:

• PDA Technical Report 39• PDA Technical Report 46• PDA Technical Report 52

• PDA Technical Report 53• PDA Technical Report 58


PDA Technical Report No. 59 (TR 59) Utilization of Statistical Methods for Production Monitoring

Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring is the latest produced as part of

PDA’s Paradigm Change in Manufacturing OperationsSM initiative. This technical report will present relevant and easy to use statistical process control methods that are applicable to our industry.


PDA Technical Reports & ResourcesPDA 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 Report No. 55 (TR 55) Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4, 6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries

This technical report provides guidance on how to detect and mitigate TBA and TCA odors and taints. TR 55 features knowledge from the food and beverage industries regarding the origin of these odors and taints, analytical methods developed and risk management strategies employed.

Available in digital version only 2012. 91 pages. Item No. 43494 Member: $150 / Nonmember: $250 / Government: $75

PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

This technical report provides detailed guidance for the application and implementation of quality risk management principles throughout the product lifecycle.


PDA Technical Report 30 Revised 2012, (TR 30) Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat

This document provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release program for pharmaceutical and medical device products terminally sterilized by moist heat.

Available in digital version only 2012. 34 pages. Item No. 43234 Member: $150 / Non-Member: $250 / Government: $75

PDA Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution

The Risk Management for Temperature-Controlled Distribution Task Force has produced a comprehensive technical report that will help manufacturers and distributors apply risk management to distribution practices.


PDA Technical Report No. 57 (TR 57) Analytical Method Validation and Transfer for Biotechnology Products

Technical Report No. 57 provides risk-based guidance for the validating methods following their development or qualification. It also contains risk-based guidance for other, related method lifecycle steps, such as analytical method transfer.


PDA Technical Report No. 56 (TR 56) Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance

PDA Technical Report No. 56 covers phase-appropriate CGMPs during the manufacturing of therapeutic protein drug substance (biological active substance) from the R&D stage through completion of phase 3 clinical trials.








PDA Bookstore


PDA Technical Report 53 (TR 53) Guidance for Industry: Stability Testing to Support Distribution of New Drug Products

Technical Report No. 53 will help any drug manufacturer provide a scientific rationale for the stability testing done to ensure the quality of drug products during shipping and storage, including excursions from temperatures outside recommended range.

Available in digital version only2011. 29 pages. Item No. 43492 Member: $150 / Non-Member: $250 / Government: $75

PDA Technical Report 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain

Anyone involved with the shipping and distribution of pharmaceutical products will benefit from Technical Report No. 52: Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain.

Print version: Item No. 01052 Digital version: Item No. 43491

2011. 36 pages. Member: $150 / Non-Member: $250 / Government: $75

PDA Technical Report 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products

The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global industry over the last fifteen years.

Available in digital version only 2011. 50 pages. Item No. 43226

Member: $150 / Non-Member: $250 / Government: $75

New MeMBeR BeNefiT:

PDA’s Technical Report PortalIn this new technical report portal, PDA Standard & 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).

To learn more, visit www.pda.org








PDA Technical Reports

No. TitleDate of

PublicationPaper

versionDigital

version

1 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control

1980 (Revised ’07) 01001 43381

3 Validation of Dry Heat Processes Used for Sterilization and Depyrogenation

1981 43208

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 1990 (Revised ’01) 43218

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

1992 (Revised ’08) 01014 43220

15 Validation of Tangential Flow Filtration in Biopharmaceutical Applications

1992 (Revised ’09) 01015 43221

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































PDA Bookstore


No. TitleDate of

PublicationPaper

versionDigital

version

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 1996 (Revised ’11) 43226

23 Industry Survey on Current Sterile Filtration Practices 1996 43227


25 Blend Uniformity Analysis: Validation and In-Process Testing 1997 43229

26 Sterilizing Filtration of Liquids 1998 (Revised ’08) 43230

27 Pharmaceutical Package Integrity 1998 43231

28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

1998 (Revised ’06) 01028 43232

29 Points to Consider for Cleaning Validation 1998 (Revised ’12) 43233

30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat

1999 (Revised ’12) 43234

31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems

1999 01031 43235

32 Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations

1999 (Revised ’04) 01032 43236

33 Evaluation, Validation and Implementation of New Microbiogical Testing Methods

2000 01033 43238

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

2001 01034 43239

35 A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry

2001 01035 43240

This list is current as of 10.17.12 | For a complete list of PDA Technical Reports, please visit www.pda.org/technicalreports




























No. TitleDate of

PublicationPaper

versionDigital

version


38Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC): Chemistry, Manufacturing and Controls Documentation

2006 01038 43315

39Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment

2007 01039 43312

40 Sterilization Filtration of Gases 2005 01040 43314

41 Virus Filtration 2008 01041 43313

42 Process Validation of Protein Manufacturing 2005 01042 43311

43Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing

2007 01043 43396

44 Quality Risk Management for Aseptic Processes 2008 01044 43410

45 Filtration of Liquids Using Cellulose-Based Depth Filters 2008 01045 43422

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

2009 01046 43485

47 Preparation of Virus Spikes Used for Virus Clearance Studies 2010 43486

48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

2010 43487

49 Points to Consider for Biotechnology Cleaning Validation 2010 43488

50 Alternative Methods for Mycoplasma Testing 2010 43489

51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use

2010 43490

PDA Technical Reports (continued)


























PDA Bookstore


No. TitleDate of

PublicationPaper

versionDigital

version

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

54 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

2012 43493

55Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries

2012 43494

56 Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance

2012 43496

57 Analytical Method Validation and Transfer for Biotechnology Products

2012 43497

58 Risk Management for Temperature-Controlled Distribution 2012 43498

59 Utilization of Statistical Methods for Production Monitoring 2012 43500

60 Process Validation: A Lifecycle Approach 2012 43501

THe PDA BOOkSTORe

How to OrderOnline purchasing is quick and easy! To order a publication from this catalog please visit www.pda.org/bookstore and enter in the item number located at the bottom of the publication description.

fax or Mail: To fax or mail your order, please visit www.pda.org/bookorder and complete the order form using the information in this brochure or online.

For a complete list of publications and more detailed information, please visit www.pda.org/bookstore. Become a PDA member and save substantially on your purchase order; for more information, visit www.pda.org/join.

This list is current as of 10.17.12 | For a complete list of PDA Technical Reports, please visit www.pda.org/technicalreports











FDA Sterile Drug Process Inspections Program 7356.002A

This narrated slide presentation, developed using FDAs Sterile Drug Process Inspections Program, provides industry operational groups with FDAs current GMPs interpretations for the manufacture and control of all sterile pharmaceuticals products including sterile bulk drugs. It consists of 291 slides and is approximately 62 minutes in length.

2011. Item No. 11107 Member: $300 / Non-Member: $360 / Government: $150

Quality Assurance Handbook Guideline for Production And Control Practices For Bulk API Chemicals

This QA Handbook contains guidelines in two areas involved with the production and control of bulk API chemicals. The first area covers chemical manufacturing and quality control responsibilities for production and control operations for bulk chemicals. The second covers the production and control practices involved in the production of APIs. CD – documents in PDF format.

28 pages. Item No. 11108 Member: $200 / Non-Member: $240 / Government: $150

FDA’s Proposed Current Good Manufacturing Practice in Manufacture, Processing, Packing or Holding of Large Volume Parenterals

These proposed regulations were published by FDA as current good manufacturing practices for large volume parenterals. This proposal is an excellent source of information, guidance and training for large volume and small volume parenterals operational personnel and management. A 128-minutes presentation and 234 slides.

2012. Item No. 11109 Member: $300 / Non-Member: $360 / Government: $150

Multimedia Training Tools




PDA Bookstore


Housed on the Stanford University’s HighWire Press platform, the online Journal features many advanced research and application tools including:

• Advanced research tools such as taxonomic browsing, content collections, sequence and structure database links, citation mapping and more

• Content is displayed in full text HTML pages or as PDFs for maximum flexibility

• High power search tools• PowerPoint downloads• RSS feeds• And much more

The PDA Journal of Pharmaceutical Science and Technology (The Journal) Journal.pda.org

Journal articles are categorized into the following areas: review, research, technology/application (or case studies), conference proceedings, editorial, commentary, technology briefs (which are comprised of audio of poster presentations) and letters to the Editor.

Accessing the Journal

PDA Membership AccessPDA Members receive an individual subscription to the PDA Journal of Pharmaceutical Science and Technology online as part of their membership fee. The membership subscription includes free access to the current volume year.

Nonmember AccessNonmembers can access abstracts, search the current issue and the archives, read articles on a pay-per-view basis, register for eTOCs and other Email Alerts or join PDA for a membership subscription.

institutional Subscribers Institutions that subscribe to the PDA Journal of Pharmaceutical Science and Technology online can register their IP addresses according to the terms of their subscription.

For more information, please visit journal.pda.org, contact +1 301-656-5900 or [email protected].

Subscribers receive fRee

legacy Content from 1989!

The PDA Journal of Pharmaceutical Science and Technology (The

Journal), established in 1947, is considered one of the most relevant

and highly cited vehicles for peer-reviewed scientific and technical papers

in the pharmaceutical and biotech industries.

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Suite 150Bethesda, MD 20814 USA

www.pda.orgTel: +1 (301) 656-5900Fax: +1 (301) 986-1361

inside: PDA Bookstore – Today’s Leading

Bio/Pharmaceutical Publications and

Resources for Your Professional

Library

Join PDA Today!PDA is a global non-profit organization of over 9,500 members. Our focus and

emphasis is in the areas of sterile product technology, biotechnology and

quality and regulatory compliance concepts and systems – become a

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