Publisher description for Good pharmaceutical manufacturing practice : rationale and compliance / John Sharp.


Bibliographic record and links to related information available from the Library of Congress catalog


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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.




Library of Congress subject headings for this publication:
Drugs -- Standards -- United States.
Drugs -- Standards -- European Union Countries.
Pharmaceutical industry -- United States -- Quality control.
Pharmaceutical industry -- European Union Countries -- Quality control.
Drugs -- Law and legislation -- United States.
Drugs -- Law and legislation -- European Union Countries.