Good Pharmaceutical Manufacturing Practice: Rationale and Compliance, 1st Edition (Hardback) book cover

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance, 1st Edition

By John Sharp

CRC Press

520 pages | 39 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9780849319945
pub: 2004-10-15
eBook (VitalSource) : 9780429205446
pub: 2004-10-15
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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.


"…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

Table of Contents

Introduction - StatU.S. and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues

Personnel, Organization and Training

Premises/Buildings and Facilities

Contamination and Contamination Control


Materials Control

Production and Process Controls

Packaging and Labelling Control

Holding and Distribution

Laboratory Controls

Records and Reports

Returned and Salvaged Products

Sterile Products

Other GMP Issues

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology