Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

by John Sharp
     
 

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.

Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing

Overview

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.

Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.

This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Editorial Reviews

Doody's Review Service
Reviewer: 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.
3 Stars from Doody

Product Details

ISBN-13:
9780849319945
Publisher:
Taylor & Francis
Publication date:
08/30/2004
Edition description:
New Edition
Pages:
520
Product dimensions:
7.00(w) x 10.10(h) x 1.30(d)

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