Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

John Sharp

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Paperback

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English

CRC Press
23 September 2019

Pharmaceutical industries; Health systems & services; Pharmaceutical technology

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.

By: John Sharp
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 254mm, Width: 178mm,
Weight: 884g
ISBN: 9780367393779
ISBN 10: 0367393778
Pages: 520
Publication Date: 23 September 2019
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

Introduction - Status and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues. Personnel, Organization and Training. Premises/Buildings and Facilities. Contamination and Contamination Control. Equipment. Materials Control. Production and Process Controls. Packaging and Labeling Control. Holding and Distribution. Laboratory Controls. Records and Reports. Returned and Salvaged products. Sterile Products Manufacture. Other GMP Issues.

Sharp, John

Reviews for Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

...provides a pleasantly different approach to the destination of GMP compliance....represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future. -European Journal of Parenteral and Pharmaceutical Sciences ...gives an immediate and good overview of the differences and similarities between the US and EU interpretation of...how to deal with Good Manufacturing Practices. --GMP Review