John Sharp

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

• Broschiertes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 520
• Erscheinungstermin: 23. September 2019
• Englisch
• Abmessung: 251mm x 178mm x 28mm
• Gewicht: 576g
• ISBN-13: 9780367393779
• ISBN-10: 0367393778
• Artikelnr.: 57815693

Autorenporträt

Sharp, John

Inhaltsangabe

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.