Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.
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"...an invaluable resource." -- Unlisted Drugs
"I am pleased to add this edition to my bookshelf!" -- European Journal of Pharmaceutics and Biopharmaceutics
"...an invaluable text....help[s] any individual or student learn the application of the CGMPs." -- Pharmaceutical Research
"...excellent in presentation and language....a value to anyone interested in drug manufacture." -- American Journal of Pharmaceutical Education
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