Description
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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Taking into account a raft of major changes in relevant governmental agencies and in the manufacturing industry, this volume addresses US law and policy affecting domestic and multinational pharmaceutical manufacturing. The author (law and the health sciences, emeritus, Temple U. and consultant) begins with the status and applicability of US regulations and current good manufacturing practices (CGMPs) in many aspects of the pharmaceuticals business, including personnel, facilities, equipment, production, packaging, labeling, distribution, laboratory controls, records, and returned and salvaged drug products. The remainder of the volume addresses issues such as TQM and the pharmacist, recalls, controlled substance safeguards, US compliance inspection procedures, FDA pre-approved inspections and investigations, and import and export of pharmaceuticals. Appendices present selections from the text of several legal procedures and documents. For pharmaceutical manufacturers, private and governmental inspection agencies, and quality assurance organizations. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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