- Shopping Bag ( 0 items )
Doody's Review ServiceReviewer: Thomas L. Pazdernik, PhD (University of Kansas Medical Center)
Description: This is how-to-do-it manual brings together important information from more than 20 different worldwide official regulatory documents on good pharmaceutical manufacturing practice.
Purpose: The purpose of this offering is to bring together in one source the most important information referred to as regulations, guides, or guidelines from over 20 documents. It draws most heavily from two very important resources available in the public domain: The United States Current Good Manufacturing Practice Regulations (cGMPs) and the European Commission's Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use (the EC GMP Guide). The author does an excellent job in meeting this goal.
Audience: This book is a very important addition to the personal library of anyone who is involved in the regulatory process for pharmaceutical products.
Features: The first chapter compares and contrasts the principles and rationales of Good Manufacturing Practice (GMP), drawing most extensively from the U.S. cGMPs and EC GMP Guide. This is followed by several chapters dealing with personnel, facilities, contamination control, equipment, materials, production, packaging and labeling, holding and distribution, laboratory controls, records and reports, and how to deal with returned products issues. There is a chapter devoted to the basic principles of manufacturing sterile products followed by a chapter on GMP and quality assurance in their manufacturing. There are separate chapters dealing with validation of both the general principles as well as the applications of good manufacturing practice. The last chapter provides a concluding comparison of the U.S. cGMPs and the EC GMP Guide.
Assessment: I strongly recommend this book as a must resource for anyone involved in good pharmaceutical manufacturing practice of products for the international market.