Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer: Fifth Edition, / Edition 5

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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.

The book contains black-and-white illustrations.

This book examines U.S. 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.

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Editorial Reviews

Pharmaceutical Research
" invaluable[s] any individual or student learn the application of the CGMPs."
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 (
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Product Details

  • ISBN-13: 9780824704254
  • Publisher: Taylor & Francis
  • Publication date: 10/12/2000
  • Series: Drugs and the Pharmaceutical Sciences Series
  • Edition description: REVISED
  • Edition number: 5
  • Pages: 752
  • Product dimensions: 6.10 (w) x 9.10 (h) x 1.60 (d)

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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