Good Pharmaceutical Manufacturing Practice: Rationale and Compliance - John Sharp - Boeken - Taylor & Francis Ltd - 9780367393779 - 23 september 2019
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Good Pharmaceutical Manufacturing Practice: Rationale and Compliance 1e uitgave

John Sharp

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Good Pharmaceutical Manufacturing Practice: Rationale and Compliance 1e uitgave

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

Media Boeken     Paperback Book   (Boek met zachte kaft en gelijmde rug)
Vrijgegeven 23 september 2019
ISBN13 9780367393779
Uitgevers Taylor & Francis Ltd
Pagina's 520
Afmetingen 884 g
Taal en grammatica Engels  

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