| Edition |
Sixth edition / edited by Joseph D. Nally. |
| Description |
viii, 398 pages : illustrations. |
| Series |
Drugs and the pharmaceutical sciences, 0360-2583 ; v. 169 |
|
Drugs and the pharmaceutical sciences ; v. 169.
|
| Note |
Rev. ed. of: Good manufacturing practices for pharmaceuticals / Sidney H. Willig. 5th ed., rev. and expanded. |
| Bibliography |
Includes bibliographical references and index. |
| 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. |
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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. |
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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. Controlled 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. |
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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. |
| Subject |
Pharmaceutical Preparations -- standards -- United States.
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Drug Industry -- standards -- United States.
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Legislation, Drug -- United States.
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Quality Control -- United States.
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Technology, Pharmaceutical -- standards -- United States.
|
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Pharmaceutical industry -- Quality control.
|
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Drugs -- Standards -- United States.
|
| Added Author |
Dally, Joseph D.
|
|
Willig, Sidney H., 1919-
Good manufacturing practices for pharmaceuticals.
|
| ISBN |
9780849339721 hardcover alkaline paper |
|
0849339723 hardcover alkaline paper |
|
