عنوان

Good manufacturing practices for pharmaceuticals

electronic

Good manufacturing practices for pharmaceuticals

New York, NY

Informa Healthcare

2007

viii, 398 p. : ill. ; 26 cm

Drugs and the pharmaceutical sciences,0630-3852 ;v. 961

Includes bibliographical references and index

edited by Joseph D. Nally

6th ed

Preface / Joseph D. Nally -- Contributors -- 1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs / Joseph D. Nally -- 2. Finished Pharmaceuticals: General Provisions, Subpart A / Joseph D. Nally -- 3. Organization and Personnel, Subpart B / Joanne W. Cochran and Joseph D. Nally -- 4. Buildings and Facilities, Subpart C / Robert Del Ciello -- 5. Equipment, Subpart D / Robert Del Ciello, Joseph T. Busfield, and Steven Ostrove -- 6. Control of Components and Drug Product Containers and Closures , Subpart E / Arlyn R. Sibille -- 7. Production and Process Controls, Subpart F / Joseph D. Nally and Michael D. Karaim -- 8. Packaging and Labeling Control, Subpart G / Arlyn R. Sibille -- 9. Holding Distribution, Subpart H / Joseph D. Nally -- 01. Laboratory Controls, Subpart I / Wayne J. DeWitte and Lex M. Hoinowski -- 11. Records and Reports, Subpart J / Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura L. Nally -- 21. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally -- 31. Repacking and Relabeling / Joseph D. Nally -- 41. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally -- 51. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn -- 61. Contracting and Outsourcing / Graham Bunn -- 71. Active Pharmaceutical Ingredients / P. Denis Celentano -- 81. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein -- 91. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally -- 02. Control Substances Safeguards )12 CFR 0031, et seq.( / Joseph D. Nally -- 12. The Inspection Procedures for Compliance in the United States: The Regulatee is Inspected; The Rational for Inspection )12 USC 373, 473( / Joseph D. Nally -- 22. FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes in the Food and Drug Modernization Act / Joseph D. Nally -- 32. World-Wide Good Manufacturings Practices / Joseph D. Nally -- 42. Quality Approaches: ISO 0009, Malcolm Baldrige, and Six Sigma / Joseph D. Nally -- Appendix A: Center for Drug Evaluation and Research: List of Guidance Documents -- Appendix B: ICH Guidelines -- Appendix C: Food and Drug Administration )FDA( Office Regulatory Affairs )ORA( Compliance Policy Guides -- Index

Quality control ، Pharmaceutical industry

Standards ، Drugs - United States

standard ، Pharmaceutical Preparations

standard ، Drug Industry

، Legislation, Drug

، Quality Control

standard ، Technology, Pharmaceutical

، United States

TI

AU Nally, Joseph D

SE