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Good manufacturing practices for pharmaceuticals : a plan for total quality control from manufacturer to consumer

Author: Sidney H Willig
Publisher: New York : Dekker, ©2001
Edition/Format:   Print book : English : 5. ed. rev. expView all editions and formats
Summary:

Examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. This book recommends pragmatic ways to interpret and comply with FDA CGMP regulation and  Read more...

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Document Type: Book
All Authors / Contributors: Sidney H Willig
ISBN: 0824704258 9780824704254
OCLC Number: 474643018
Description: xii, 732 s
Contents: Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of DrugsFinished 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 RelabelingBulk Pharmaceutical ChemicalsThe Pharmacist and Total Quality ControlRecalls and CGMPs: Enforcement Alternatives in the United StatesControlled 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 ActWho is the Manufacturer? Some Additional Considerations for the MultinationalOther GMPsOther Approaches to QualityImport and Export of Pharmaceuticals and Other ProductsSubject to CGMPsEnhancement of Global Product DistributionAppendix A: Food and Drug Modernization Act of 1997-in Pertinent PartAppendix B: Components/RepackagersAppendix C: Hearing Procedures When FDA Proposes the Imposition of Civil Money PenaltiesAppendix D:Section 601.12 Changes Currently Considered "Important" by CBERAppendix E: USP24-NF19 Information; Monographs; Tests
Responsibility: Sidney H. Willig

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