Two-Volume Biopharmaceutical Publication Available at PDA Bookstore

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

By Destin LeBlanc
The two volumes Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated collection of his Cleaning Memos. Volume 1 originally published from 2000-2004 and Volume 2 published from January 2005 through December 2008. In both volumes, each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics rather than chronologically. The benefit to having both volumes at hand, aside from gaining full insight into ten years of subject-matter expert advice, is its accessibility by common subject.

Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1 & II
Edited by Richard Prince, PhD
The first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. Modeled on the first edition, the 2008 completely revised and extended edition raises the bar by offering practical and current industrial and regulatory perspectives. While in revision, 20 new chapters were added and sixteen new authors contributed their work to this book making it the most comprehensive collection of best thinking from subject matter experts in their respective fields.

Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection
By Jeanne Moldenhauer
The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available on its website. The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements, making them easier to look at in a systematic fashion.

Water Activity Applications in the Pharmaceutical Industry
Edited by Anthony M. Cundell, PhD and Anthony J. Fontana, PhD
This book examines the fundamentals and relationships of water activity, ranging from the measurement of moisture content, water activity, and water sorption isotherms, to ways in which water activity affects microorganisms, chemical reaction rates, drug product formulation and processing and physical properties, water activity as a hurdle, and applications of water activity management in the pharmaceutical industry.

Available for purchase at the PDA Bookstore
PDA Technical Report 22, (TR 22) Revised 2011
Process Simulation for Aseptically Filled Products:

PDA Technical Report 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products, originally published in 1996. 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 decade and a half. They have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area. In addition the report provides guidance where risk-based approaches may be applied. Learn more.

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