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04164aam a2200397Ia 4500 001 FCCC2D98026611E89DEE1C1997128E48 003 SILO 005 20180126010225 008 070115t20072007nyua b 001 0 eng 020 $a 9780849339721 020 $a 0849339723 035 $a (OCoLC)78051859 040 $a UNM $c UNM $d BAKER $d YDXCP $d UAT $d IXA $d UtOrBLW $d SILO 050 4 $a RS189 $b .G66 2007 245 00 $a Good manufacturing practices for pharmaceuticals / $c edited by Joseph D. Nally. 250 $a Sixth edition. 264 1 $a New York. NY : $b Informa Healthcare, $c [2007] 300 $a viii, 398 pages : $b illustrations ; $c 24 cm. 490 1 $a Drugs and the pharmaceutical sciences, $x 0360-2583 ; $v v. 169 504 $a Includes bibliographical references and index. 505 0 $a 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 -- 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 -- 505 8 $a 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 -- 505 8 $a 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 $a Pharmaceutical industry $x Quality control. $0 http://id.loc.gov/authorities/subjects/sh2008109170 650 0 $a Drugs $x Standards $z United States. $0 http://id.loc.gov/authorities/subjects/sh2009123923 650 2 $a Pharmaceutical Preparations $x standard. $2 [MeSH] 650 2 $a Drug Industry $x standard. $2 [MeSH] 650 2 $a Legislation, Drug. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D007880 650 2 $a Quality Control. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D011786 650 2 $a Technology, Pharmaceutical $x standard. $2 [MeSH] 651 2 $a United States. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D014481 700 1 $a Nally, Joseph D. $0 http://id.loc.gov/authorities/names/n2007181053 830 0 $a Drugs and the pharmaceutical sciences ; $v v. 169. $0 http://id.loc.gov/authorities/names/n42009973 941 $a 1 952 $l OVUX522 $d 20180126014714.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=FCCC2D98026611E89DEE1C1997128E48Initiate Another SILO Locator Search