ISBN: 0824704258 Title: Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, 5th edition (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs) Author: Sidney H. Wig Publisher: Informa Healthcare Publication Date: 2000-11-15 Number Of Pages: 732 Average Amazon Rating: 5.0
Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, 5th edition
Summary: 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.
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.
Good Manufacturing Practices for Pharmaceuticals, Sixth Edition A Plan for Total Quality Control from Manufacturer to Consumer, Sixth Edition Editors: Joseph D. Nally ISBN: 978-0-8493-3972-1 (hardback) 978-1-4200-2093-9 (electronic) Series: Drugs and the Pharmaceutical Sciences Subjects: Analysis & Pharmaceutical Quality; Pharmaceutical Manufacturing; Pharmaceutical Science Regulatory; Publisher: Informa Healthcare, USA Purchase eBook: US$169.95 - buy now add to cart Sign In Purchase Printed Book This book is not available as an ebook on Informaworld. If you would like to receive information about this title, please email us at books@informausa.com Summary With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. Table of Contents Status and Applicability of U.S. Regulations. Finished Pharmaceuticals General Provisions (Subpart A). Organization and Personnel (Subpart B). Buildings and Facilities (Subpart C). Equipment (Subpart D). Control of Components and Drug Product Containers and Closures (Subpart E). Production and Process Controls (Subpart F). Packaging and Labeling Control (Subpart G). Holding and Distribution (Subpart H). Laboratory Controls (Subpart I). Records and Reports (Subpart J). Returned and Salvaged Drug Products (Subpart K). Repacking and Relabeling. Quality Systems and Risk Management Approaches. Clinical Trial Supplies and GMPs. Contracting and Outsourcing. Active Pharmaceutical Ingredients. Bulk Pharmaceutical Excipient GMPs. Recalls, Warning Letter, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States. Controlled Substances Safeguards. The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection. FDA Pre-Approval Inspections/Investigations: The Road from SUPAC to the Food and Drug Modernization Act. Worldwide GMPs. Quality Approaches: ISO 9000, Malcolm Baldrige and Six Sigma. Appendix A: Center for Drug Evaluation and Research (CDER) List of Guidance Documents. Appendix B: ICH Guidelines. Appendix C: FDA / ORA Compliance Policy Guides
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