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Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Hardcover

Medical ReferenceChemistry

ISBN10: 0849319943
ISBN13: 9780849319945
Publisher: Crc Pr Inc
Published: Oct 15 2004
Pages: 520
Weight: 2.35
Height: 1.28 Width: 7.16 Depth: 10.30
Language: English
Bridging the gap between U.S. cGMP Regulations and European GMP guidelines, this book presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use(EU GMP guide). Drawing on more than forty years of experience, the author explores the reasoning behind the requirements. 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 an international capacity.

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