Good Pharmaceutical Manufacturing Practice - John Sharp

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

(Autor)

Buch | Softcover
520 Seiten
2019
CRC Press (Verlag)
978-0-367-39377-9 (ISBN)
77,30 inkl. MwSt
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.

Sharp, John

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.

Erscheinungsdatum
Verlagsort London
Sprache englisch
Maße 178 x 254 mm
Gewicht 884 g
Themenwelt Medizin / Pharmazie Allgemeines / Lexika
Medizin / Pharmazie Gesundheitswesen
Medizin / Pharmazie Pharmazie
Naturwissenschaften Biologie
Technik
ISBN-10 0-367-39377-8 / 0367393778
ISBN-13 978-0-367-39377-9 / 9780367393779
Zustand Neuware
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