Good Pharmaceutical Manufacturing Practice: Rationale and...

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Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Name: Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
ISBN: 9780849319945

John Sharp

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Bridging the gap between US regulations and European Good Manufacturing Practice guidelines, Sharp (European Journal of Parenteral and Pharmaceutical Sciences) explains the essence of material from the US 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). He compares the principal requirements in both systems, and explores the reasoning behind these requirements outlines ways to comply with them. Coverage encompasses personnel and facilities management as well as manufacturing. The book will be useful for those who wish to expand their pharmaceutical business

Thể loại:

Medicine

Năm:

2004

In lần thứ:

Nhà xuát bản:

Informa Healthcare

Ngôn ngữ:

english

Trang:

515

ISBN 10: