| Record ID | marc_loc_updates/v35.i17.records.utf8:12544871:3651 |
| Source | Library of Congress |
| Download Link | /show-records/marc_loc_updates/v35.i17.records.utf8:12544871:3651?format=raw |
LEADER: 03651cam a22003617a 4500
001 2007272501
003 DLC
005 20070420113427.0
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
042 $alccopycat
050 00 $aRS189$b.W57 2007
245 00 $aGood manufacturing practices for pharmaceuticals /$cedited by Joseph D. Nally.
250 $a6th ed.
260 $aNew York, NY :$bInforma Healthcare,$cc2007.
300 $aviii, 398 p. :$bill. ;$c26 cm.
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 42 $3Publisher description$uhttp://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html