An edition of Good manufacturing practices for pharmaceuticals
(2007)
Good manufacturing practices for pharmaceuticals
6th ed.
by Joseph D. Nally
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| Edition | Availability |
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1
Good Manufacturing Practices for Pharmaceuticals
2016, Taylor & Francis Group
in English
1420020935 9781420020939
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2
Good manufacturing practices for pharmaceuticals
2007, Informa Healthcare, Brand: CRC Press
in English
- 6th ed.
0849339723 9780849339721
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Book Details
Table of Contents
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.
Edition Notes
Includes bibliographical references and index.
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| April 6, 2023 | Edited by ImportBot | import existing book |
| August 1, 2020 | Edited by ImportBot | import existing book |
| February 13, 2019 | Created by MARC Bot | import existing book |