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Production / Manufacturing |
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Good Manufacturing Practices for Pharmaceuticals
A Plan for Total Quality Control from Manufacturer to Consumer, 5th edition
Publication Date October 2000
Publisher Taylor & Francis Ltd
Product Type Book
Pages 752
ISBN Number 0824704258
Product Code TFL001
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Summary
This newly revised and expanded reference examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA Current Good Manufacturing Practice (CGMP) regulation and related criteria, and focusing 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. Fifth Edition covers cross-licensing, joint ventures, strategic alliances, mergers, acquisitions, and divestitures that emphasize the necessity of maintaining quality control!
Adds descriptions of the Malcolm Baldrige National Quality Award and the ISO 9000 that drive customer satisfaction.
Highlighting key issues and differences among GMPs of Europe, Canada, and the World Health Organization, the Fifth Edition of Good Manufacturing Practices for Pharmaceuticals
* includes new material regarding health-related food labeling and homeopathic remedies
* provides timely access to new USP24 – NF19 information, titles, and tests
* recommends establishing a written CGMP compliance program for each manufacturing facility and setting a calendar for review and update
* offers compliance guides to facilitate in house educational programs
* stresses willingness to report circumstances that indicate insufficient oversight and misconduct
* reveals advances in pharmaceutical design, clarifying complexities in the production process from packaging to storage
* features a professional approach to current good dispensing practices for pharmacists and other authorized drug dispensers
* addresses growing concerns of product adulteration and misbranding
* discusses the application of CGMPs to the manufacture of bulk pharmaceutical chemicals
* and more!
Examining the nexus of pharmaceutical manufacture, distribution, testing, and the professional practice of pharmacy, the Fifth Edition of Good Manufacturing Practices for Pharmaceuticals is the definitive reference for pharmacists; pharmaceutical quality control and reliability managers; regulatory affairs professionals and attorneys; federal, state, and local officials responsible for compliance; international pharmaceutical manufacturers, exporters, and importers; and upper-level undergraduate and graduate students in these disciplines.
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