Overview

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.

Full Product Details

Author:   D. Nally Joseph (Eastman Kodak Corporation, New York, New York, USA)
Publisher:   Taylor & Francis Ebooks
Imprint:   Marcel Dekker Ltd
Edition:   5th New edition
ISBN:  

9780824741938

ISBN 10:   0824741935
Pages:   752
Publication Date:   12 October 2000
Audience:   Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Replaced By:   9781420020939
Format:   Undefined
Publisher's Status:   Out of Print
Availability:   Out of stock  

Table of Contents

"Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of Drugs 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 Controls (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 Bulk Pharmaceutical Chemicals The Pharmacist and Total Quality Control Recalls and CGMPs: Enforcement Alternatives in the United States Controlled Substances Safeguards (21 CFR 1300, et seq.) The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection (21 USC 373,374) FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization Act Who is the Manufacturer? Some Additional Considerations for the Multinational Other GMPs Other Approaches to Quality Import and Export of Pharmaceuticals and Other Products Subject to CGMPs Enhancement of Global Product Distribution Appendix A: Food and Drug Modernization Act of 1997-in Pertinent Part Appendix B: Components/Repackagers Appendix C: Hearing Procedures When FDA Proposes the Imposition of Civil Money Penalties Appendix D:Section 601.12 Changes Currently Considered ""Important"" by CBER Appendix E: USP24-NF19 Information; Monographs; Tests"

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