Overview

With over twenty different official regulatory statements, national and international, 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 compares the principle requirements of GMP, explores the reasoning behind these requirements, and ways to comply with them. 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.

Full Product Details

9780849319945

Table of Contents

Reviews

""…provides a pleasantly different approach to the destination of GMP compliance….represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future."" -European Journal of Parenteral and Pharmaceutical Sciences ""…gives an immediate and good overview of the differences and similarities between the US and EU interpretation of…how to deal with Good Manufacturing Practices."" --GMP Review

...provides a pleasantly different approach to the destination of GMP compliance....represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future. -European Journal of Parenteral and Pharmaceutical Sciences ...gives an immediate and good overview of the differences and similarities between the US and EU interpretation of...how to deal with Good Manufacturing Practices. --GMP Review

Author Information

Sharp, John

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