Good Pharmaceutical Manufacturing Practice

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Sprache: Englisch

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Beschreibung

Bridging the gap between U.S. cGMP Regulations and European GMP guidelines, this book presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use(EU GMP guide). Drawing on more than forty years of experience, the author explores the reasoning behind the requirements. 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 an international capacity.

Über den Autor

Sharp, John

Inhaltsverzeichnis

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.

Details

Erscheinungsjahr:	2019
Fachbereich:	Andere Fachgebiete
Genre:	Importe , Medizin
Rubrik:	Wissenschaften
Medium:	Taschenbuch
ISBN-13:	9780367393779
ISBN-10:	0367393778
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Sharp, John
Hersteller:	CRC Press
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	254 x 178 x 28 mm
Von/Mit:	John Sharp
Erscheinungsdatum:	23.09.2019
Gewicht:	0,967 kg