Good manufacturing practices for pharmaceuticals
By: edited by Joseph D. Nally.
Contributors: Nally, Joseph D.
Edition: 6th ed.
Series: Drugs and the pharmaceutical sciences -- v. 169
Publisher: Informa Healthcare; Brand: CRC Press
Published: 2007
Place of publication: New York, NY
Language: eng
Number of pages: 398
ISBN-13: 9780849339721
Subjects: Pharmaceutical industry -- Quality control; Drugs -- Standards -- United States; Pharmaceutical Preparations -- standard; Drug Industry -- standard; Legislation, Drug; Quality Control; Technology, Pharmaceutical -- standard; United States
Notes: Includes bibliographical references and index.
Table of contents: title: Preface / Joseph D. Nally; title: Contributors; title: 1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs / Joseph D. Nally; title: 2. Finished Pharmaceuticals: General Provisions, Subpart A / Joseph D. Nally; title: 3. Organization and Personnel, Subpart B / Joanne W. Cochran and Joseph D. Nally; title: 4. Buildings and Facilities, Subpart C / Robert Del Ciello; title: 5. Equipment, Subpart D / Robert Del Ciello, Joseph T. Busfield, and Steven Ostrove; title: 6. Control of Components and Drug Product Containers and Closures , Subpart E / Arlyn R. Sibille; title: 7. Production and Process Controls, Subpart F / Joseph D. Nally and Michael D. Karaim; title: 8. Packaging and Labeling Control, Subpart G / Arlyn R. Sibille; title: 9. Holding Distribution, Subpart H / Joseph D. Nally; title: 10. Laboratory Controls, Subpart I / Wayne J. DeWitte and Lex M. Hoinowski; title: 11. Records and Reports, Subpart J / Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura L. Nally; title: 12. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally; title: 13. Repacking and Relabeling / Joseph D. Nally; title: 14. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally; title: 15. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn; title: 16. Contracting and Outsourcing / Graham Bunn; title: 17. Active Pharmaceutical Ingredients / P. Denis Celentano; title: 18. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein; title: 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally; title: 20. Control Substances Safeguards (21 CFR 1300, et seq.) / Joseph D. Nally; title: 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; title: 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; title: 23. World-Wide Good Manufacturings Practices / Joseph D. Nally; title: 24. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma / Joseph D. Nally; title: Appendix A: Center for Drug Evaluation and Research: List of Guidance Documents; title: Appendix B: ICH Guidelines; title: Appendix C: Food and Drug Administration (FDA) Office Regulatory Affairs (ORA) Compliance Policy Guides; title: Index.