Good Pharmaceutical Manufacturing Practice: Rationale and Compliance - John Sharp - 書籍 - Taylor & Francis Ltd - 9780367393779 - 2019年9月23日
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John Sharp
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance 第1 版

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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.

520 pages

メディア 書籍     Paperback Book   (ソフトカバーで背表紙を接着した本)
リリース済み 2019年9月23日
ISBN13 9780367393779
出版社 Taylor & Francis Ltd
ページ数 520
寸法 150 × 220 × 10 mm   ·   884 g
言語 英語  

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