Nally, Joseph D. text bibliography nyu New York, NY Informa Healthcare c2007 2007 6th ed. monographic eng

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viii, 398 p. : ill. ; 26 cm. 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 -- 10. 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 -- 12. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally -- 13. Repacking and Relabeling / Joseph D. Nally -- 14. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally -- 15. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn -- 16. Contracting and Outsourcing / Graham Bunn -- 17. Active Pharmaceutical Ingredients / P. Denis Celentano -- 18. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein -- 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally -- 20. Control Substances Safeguards (21 CFR 1300, et seq.) / Joseph D. Nally -- 21. The Inspection Procedures for Compliance in the United States: The Regulatee is Inspected; The Rational for Inspection (21 USC 373, 374) / 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 -- 23. World-Wide Good Manufacturings Practices / Joseph D. Nally -- 24. Quality Approaches: ISO 9000, 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. edited by Joseph D. Nally. Includes bibliographical references and index. Pharmaceutical industry Quality control Drugs Standards United States Pharmaceutical Preparations standard Drug Industry standard Legislation, Drug Quality Control Technology, Pharmaceutical standard United States RS189 .W57 2007 615.19 GOO 0849339723 9780849339721 2007272501 http://www.loc.gov/catdir/toc/fy0709/2007272501.html http://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html http://www.loc.gov/catdir/toc/fy0709/2007272501.html http://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html UNM 070323 20150121174605.0 14781242