Good manufacturing practices for pharmaceuticals : a plan for total quality control from manufacturer to consumer
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 related criteria, they focus on geographical redistribution of manufacturing facilities, adaptation to disparate human resources, and others.
Print Book, English, ©2001
5. ed. rev. exp View all formats and editions
Dekker, New York, ©2001
xii, 732 s
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