Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer: Fifth Edition, / Edition 5 by D. Nally Joseph | 9780824704254 | Hardcover | Barnes & Noble
Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer: Fifth Edition, / Edition 5

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

by D. Nally Joseph
     
 

ISBN-10: 0824704258

ISBN-13: 9780824704254

Pub. Date: 10/12/2000

Publisher: Taylor & Francis

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

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.

Product Details

ISBN-13:
9780824704254
Publisher:
Taylor & Francis
Publication date:
10/12/2000
Series:
Drugs and the Pharmaceutical Sciences Series
Edition description:
REVISED
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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