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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
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.
300 _aviii, 398 p. :
_bill. ;
_c26 cm.
365 _aIRS
_b4995
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 _a7
_bcbc
_ccopycat
_d2
_encip
_f20
_gy-gencatlg
942 _2ddc
_cBK
955 _apv07 2007-03-23 z-processor to ASCD
_ijx09 2007-04-11
_aaa05 2007-05-03
_axb05 2009-02-06 copy 2 added
999 _c34828
_d34828