Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals

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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.ISO 9002: QUALITY SYSTEMSa€”MODEL FOR QUALITY ASSURANCE IN PRODUCTION, INSTALLATION, AND SERVICING This standard applies to more routine production where product quality requirements can be adequately expressedanbsp;...

Title:Good Manufacturing Practices for Pharmaceuticals
Author:D. Nally Joseph
Publisher:CRC Press - 2000-10-12


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