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Good Pharmaceutical Manufacturing Practice
- Rationale and Compliance
Engelsk
Bogcover for Good Pharmaceutical Manufacturing Practice af John Sharp, 9780367393779
Specifikationer
Sprog:
Engelsk
Sider:
520
ISBN-13:
9780367393779
Indbinding:
Paperback
ISBN-10:
0367393778
Udg. Dato:
23 sep 2019
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
23 sep 2019
Forfatter(e):

Good Pharmaceutical Manufacturing Practice

- Rationale and Compliance
Engelsk
Paperback 2019
Format:

Bog beskrivelse
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.



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Specifikationer
Sprog:
Engelsk
Sider:
520
ISBN-13:
9780367393779
Indbinding:
Paperback
ISBN-10:
0367393778
Udg. Dato:
23 sep 2019
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
23 sep 2019
Forfatter(e):
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