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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:

Cold Chain Chronicles: A practitioners outside-the-box perspectives on the importance of temperature-sensitive drug stewardship

Cold-Chain-Chronicles

by: Kevin O`Donnell

This book is quite different from the typical prescriptive PDA/DHI "how-to" publication. Noted pharmaceutical cold-chain expert, Kevin O'Donnell, relates a series of engaging stories carefully crafted to elevate awareness, understanding, and criticality of temperature-sensitive drug products throughout the supply chain — not only for the stakeholders involved — but for the consumer in us all. O'Donnell deftly blends his cold-chain storytelling with charm and wit, history and science, and the wisdom of a practitioner's 35 years' experience. These thought-provoking narratives convey to the reader heuristic lessons that underscore the risks involved and the impending need to improve the processes that ensure these fragile pharmaceutical products arrive to their destinations — and to the patients who need them — in a safe, controlled way.

As an added bonus for both new and experienced colleagues, the World Health Organization has granted permission allowing readers to access, either by URL or QR codes available in the book, training videos they have prepared on the subject.
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Contamination Control in Healthcare Product Manufacturing, Volume 3

Contamination Control in Healthcare Product Manufacturing V. 1

Edited by Jeanne Moldenhauer and Russell Madsen

All chapters are written by subject matter experts, each of them bringing their extensive knowledge and experience to all personnel involved in aseptic contamination control. Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with details about IREM, cleanroom classifications and disinfectant qualification testing. 2014.
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Technology and Knowledge Transfer: Keys to Successful Implementation and Management

Technology Knowledge

Edited by Mark Gibson and Siegfried Schmitt

Written by global subject matter experts, this book offers the practical experience needed to obtain a competitive edge. The successful technology transfer from research and development to the commercial production site is a critical process in the development and launch of a new medicinal product. 2014.
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Pharmaceutical Outsourcing: Quality Management and Project Delivery

Pharmaceutical Outsourcing

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

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

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

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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