Sharp, John,

Good pharmaceutical manufacturing practice : rationale and compliance / John Sharp. - New York : CRC Press, c2005. - ix, 503 p. : ill. ; 26 cm.

Includes bibliographical references and index.

Introduction: status and applicability of US regulations/EU guidelines - general quality issues --
Personnel, organization, and training --
Premises/buildings and facilities --
Contamination and contamination control --
Equipment --
Materials control --
Production and process controls --
Packaging and labeling control --
Holding and distribution --
Laboratory controls --
Records and reports --
Returned and salvaged drug products --
Sterile products manufacture - basic principles --
GMP and quality assurance in sterile products manufacture --
Validation - general principles --
Validation - applications --
Self-inspection and quality audit --
US cGMPs and EC GMP guide - concluding comparison. Table of contents

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."--BOOK JACKET.



0849319943 (alk. paper) 9780849319945

2004050322


Drugs--Standards--United States.
Drugs--Standards--European Union Countries.
Pharmaceutical industry--Quality control.--United States
Pharmaceutical industry--Quality control.--European Union Countries
Drugs--Law and legislation--United States.
Drugs--Law and legislation--European Union Countries.

RS189 / .S524 2005

615.362178273 / SHG 2005

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