PDA Technical Books

PDA Technical Books are specifically developed for the professional needs of PDA members. Written by colleagues and peer reviewed, each serves as a practical guide and reference for specific topics facing practitioners in the pharmaceutical and allied industries.

The PDA Technical Book Committee of volunteer members vets each manuscript proposal to ensure its applicability to the PDA membership.

Here are the latest releases:

Pharmaceutical Outsourcing: Quality Management and Project Delivery

Pharmaceutical Outsourcing: Quality Management and Project Delivery

Edited by Trevor Deeks, Karen Ginsbury and Susan Schniepp

This book intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators.
The editors and authors of Pharmaceutical Outsourcing: Quality Management and Project Delivery have experience with outsourcing and agreed to collaboratively publish a comprehensive, practical guide with the goal of offering sound, reasonable advice to the outsourcing community focusing mainly on contract manufacturing. 2013.
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Sterility Testing of Pharmaceutical Products

Sterility Testing of Pharmaceutical Products

By Tim Sandle

This book balances theoretical, and sometimes philosophical, discourses about the nature of sterility and the conceptual problems of microbial viability with sound practical guidance on how to validate the sterility test, problematic products as well as solutions on how to control the environment and review manufacturing process parameters, while navigating the regulatory minefield.
The aim of the book is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future and is aimed at quality assurance personnel, production staff, microbiologists, students and those with an interest in medicinal products. 2013.
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Combination Products: Implementation of cGMP Requirements

Combination Products: Implementation of cGMP Requirements

Edited by Lisa A. Hornback

The goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP in a combination product environment and also includes information from leaders in the industry regarding the unique requirements for several common combination products situations. PDA hopes that this book can answer many of the reader's questions on the evolving world of combination products. 2013.
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Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes

Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes

By Lynn Torbeck, Joyce Torbeck

The goal of Lynn and Joyce Torbeck's book, Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes, is to show that the sqrt (N) plans are statistically correct and can be used in applications that minimize risk to the patient. This book presents technical and practical information for the correct use of the three sqrt (N) attribute sampling plans. While the book is oriented to the domestic and international pharmaceutical industry, the material is general enough to be adapted to other industries and applications. 2013.
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Contamination Control in Healthcare Product Manufacturing, Volume 1

Contamination Control in Healthcare Product Manufacturing, Volume 1

Edited by Russell E. Madsen and Jeanne Moldenhauer

In this first book of the contamination control series, you will be provided with a wealth of information that can aid you in understanding the sources of contamination, types of control measures that can be used, methods to use when contamination occurs and regulatory expectations for management of these systems.

It is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use of cleaning and disinfecting agents. There is something for almost everyone who has responsibility for developing or using microbiological contamination control programs and systems. 2013.
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Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3

Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3

By Destin LeBlanc

Volume 3, a complement to Destin's two earlier books on the same subject, presents modifications and updates of his monthly Cleaning Memos originally published from January 2009 through December 2012. Each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics. For example, topics related to setting limits are in one section, those related to sampling in another section, and so forth. An appendix with a list of acronyms is included as well. 2013.
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Cleaning and Cleaning Validation, Volume 2

Cleaning and Cleaning Validation, Volume 2

Edited by Paul L. Pluta

Volume two, "Application of Basics and Principles," builds on the foundation of concepts provided in volume one. Twenty-five chapters address the lilifecycle approach to cleaning validation; discussion of specific process residues and their cleaning; equipment, including equipment to be cleaned and cleaning equipment; and, much much more!

The book contains current knowledge and approaches to cleaning and cleaning validation of pharmaceuticals, medical devices and associated products. Information provided is consistent with current regulatory documents and expectations. Practical information and case studies presented throughout the volumes will supplement the basic information with useful experiences. 2013.
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Encyclopedia of Rapid Microbiological Methods, Volume 4

Encyclopedia of Rapid Microbiological Methods, Volume 4

Edited by Michael J. Miller

Rapid microbiological methods have made amazing strides recently and this volume complements Dr. Miller's previous three volumes by offering up-to-the-minute advances, new techniques, case studies, new equipment and much more.

Contents of the Encyclopedia of Rapid Microbiological Methods, Volume 4 include details about: quality control, choosing appropriate methods, future use and technologies, mass spectrometry, genotypic methods for identification, new case studies, detection, application of USP and other guidelines, environmental monitoring, alternative tests, validation, sterility testing, mycoplasma testing, application of rapid microbiological methods as they relate to both bio-processing and regulatory considerations, many product-specific method advances and much, much more. 2013.
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