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001 | 14781242 | ||
003 | BD-DhUL | ||
005 | 20150121174605.0 | ||
008 | 070323s2007 nyua b 001 0 eng d | ||
010 | _a 2007272501 | ||
020 | _a0849339723 | ||
020 | _a9780849339721 | ||
035 | _a(OCoLC)ocm78051859 | ||
040 |
_aUNM _cUNM _dBAKER _dYDXCP _dUAT _dIXA _dDLC _dBD-DhUL |
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042 | _alccopycat | ||
050 | 0 | 0 |
_aRS189 _b.W57 2007 |
082 | 0 | 0 |
_a615.19 _222 _bGOO |
245 | 0 | 0 |
_aGood manufacturing practices for pharmaceuticals / _cedited by Joseph D. Nally. |
250 | _a6th ed. | ||
260 |
_aNew York, NY : _bInforma Healthcare, _cc2007. |
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300 |
_aviii, 398 p. : _bill. ; _c26 cm. |
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365 |
_aIRS _b4995 |
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440 | 0 |
_aDrugs and the pharmaceutical sciences, _x0360-2583 ; _vv. 169 |
|
504 | _aIncludes bibliographical references and index. | ||
505 | 0 | _aPreface / 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. | |
650 | 0 |
_aPharmaceutical industry _xQuality control. |
|
650 | 0 |
_aDrugs _xStandards _zUnited States. |
|
650 | 2 |
_aPharmaceutical Preparations _xstandard. |
|
650 | 2 |
_aDrug Industry _xstandard. |
|
650 | 2 | _aLegislation, Drug. | |
650 | 2 | _aQuality Control. | |
650 | 2 |
_aTechnology, Pharmaceutical _xstandard. |
|
651 | 2 | _aUnited States. | |
700 | 1 | _aNally, Joseph D. | |
856 | 4 | 1 |
_3Table of contents only _uhttp://www.loc.gov/catdir/toc/fy0709/2007272501.html |
856 | 4 | 2 |
_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html |
906 |
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942 |
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955 |
_apv07 2007-03-23 z-processor to ASCD _ijx09 2007-04-11 _aaa05 2007-05-03 _axb05 2009-02-06 copy 2 added |
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999 |
_c34828 _d34828 |