Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
Editorial Reviews
Review
…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
Book Description
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, this book comparatively 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). Based on the author's 40+ years experience, it offers special consideration of the reasoning behind the requirements, with specific regards to compliance methods. Topics also 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.
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance,John Sharp,CRC,0849319943,Drug Guides,Drugs,European Union Countries,General,Health Care Delivery,Medical,Pharmaceutical industry,Pharmacy,Quality control,Science,Standards,United States,Medical / Pharmacology
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