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160613s2010 nyu eng |
| 020 |
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|a 0849339723
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| 020 |
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|a 9780849339721
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| 050 |
0 |
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|a RS189
|b .G66 2010
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|a QV 771
|b .G646 2010
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|a RS189
|b .G66 2010
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| 245 |
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|a Good manufacturing practices for pharmaceuticals
|c edited by Joseph D. Nally
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| 250 |
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|a 6th ed.
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| 260 |
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|a New York, NY :
|b Informa Healthcare ,
|c c2010
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| 300 |
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|a viii, 398 p. :
|b ill. ;
|c 26 cm.
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| 440 |
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|a Drugs and the pharmaceutical sciences
|v v.169
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| 504 |
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|a Includes bibliographical references and index
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| 505 |
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|a 1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs -- 2. Finished Pharmaceuticals: General Provisions -- 3. Organization and Personnel -- 4. Buildings and Facilities -- 5. Equipment -- 6. Control of Components and Drug Product Containers and Closures -- 7. Production and Process Controls -- 8. Packaging and Labeling Contro -- 9. Holding Distribution -- 10. Laboratory Controls -- 11. Records and Reports -- 12. Returned and Salvaged Drug Products -- 13. Repacking and Relabeling -- 14. Quality Systems and Risk Management Approaches -- 15. Clinical Trial Supplies and Current Good Manufacturing -- 16. Contracting and Outsourcing -- 17. Active Pharmaceutical Ingredients -- 18. Bulk Pharmaceutical Excipient GMPs -- 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States -- 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) -- 22. FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes in the Food and Drug Modernization Act -- 23. World-Wide Good Manufacturings Practices -- 24. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma -- 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.
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| 650 |
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|a Drug Industry
|x Standard
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| 650 |
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|a Drugs
|x Standards
|z United States
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| 650 |
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0 |
|a Legislation, Drug
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| 650 |
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|a Pharmaceutical industry
|x Quality control
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| 650 |
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|a Pharmaceutical Preparations
|x Standard
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| 700 |
1 |
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|a Nally, Joseph D. ,
|e author
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| 999 |
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|a 1000166725
|b Book
|c Open Shelf (1 Day)
|e Tembila Campus
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