Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

ISBN-13: 9780367393779 / Angielski / Miękka / 2019 / 520 str.

John Sharp

Opis

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.

Recenzje

"…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

Spis treści

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.

O autorze

Sharp, John