Bio/Pharmaceutical Publications at the PDA Bookstore

By James L. Vesper
As manufacturing and distribution practices become more complex and global, manufacturers cannot simply focus on one or two sets of requirements. This publication is intended to provide you with a richer view of what current expectations are. Vesper explores more than 30 elements that are typically included in a modern pharmaceutical quality system. Each element is explained, risk-related questions are explored, and expectations are discussed.

Environmental Monitoring: A Comprehensive Handbook, Volume I, II, III, IV, V and Protocol CD
Edited by Jeanne Moldenhauer
This five volume collection, including 96 chapters written by subject matter experts worldwide, describes methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume addresses different environmental monitoring issues. Numerous useful protocols are included on the CD as well.

Validation by Design®: The Statistical Handbook for Pharmaceutical Process Validation
By Lynn D. Torbeck
This book offers an overview of the statistical issues expressed and implied in the US FDA's Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. It is an invaluable resource for anyone concerned with statistical aspects of validating a drug, biologic or animal health manufacturing process.

The Bacterial Endotoxins Test: A Practical Guide
Edited by Karen Zink McCullough
This unique book is a collection of interdependent chapters that are part lab manual, essay, historical context, consultant and plain sage advice that provides a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice that comes from the contributors` collective experience of over 200 years with BET, the book explains how standard compliance and control measures apply to this seemingly hybrid technology.

New Release: Rapid Sterility Testing
Edited by Jeanne Moldenhauer

Pre-order and Save 10% through October 31st! Understand the history, regulatory requirements and allowances for gaining approval of rapid sterility test methods. Compendial requirements for validation and implementation of these methods in the United States and Europe will also be addressed. In addition, subject matter experts will provide information on the types of methods that can be considered for aseptic sterility testing and discuss issues such as the statistical methods used to validate these methods. Also, there are a substantial number of case studies describing how various companies have approached selecting, validating and implementing new methodologies for sterility testing at their site.