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Good manufacturing practices for pharmaceuticals / edited by Joseph D. Nally.

Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 169 | Drugs and the pharmaceutical sciences ; v. 169Publication details: New York, NY : Informa Healthcare, c2007.Edition: 6th edDescription: viii, 398 p. : ill. ; 26 cmISBN:
  • 9780849339721
  • 9780849339721 (Cloth)
Subject(s): DDC classification:
  • 615.19 NAL
LOC classification:
  • RS189 .W57 2007
Contents:
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 -- 6.Control of compoents 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 and distribution: subpart H. Joseph D. Nally -- 10.Laboratory controls: subpart I. Wayne J. DeWitte and Alex M. Hoinowski -- 11.Records and reports: subpart J. Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura N. 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 ingredients. Irwin Silverstein -- 19.Recalls, warning lettters, seizures and injunctions: CGMP enforcement alternatives in the United States. Joseph D. Nally -- 20.Controlled substances safeguards. Joseph D. Nally -- 21.The inspectioin procedure for compliance in the United States: the regulatee is inspected: the rationale for inspection (21 USC 373, 374). Joseph D. Nally -- 23.Worldwide good manufacturing proactices. Joseph D. Nally -- 24.Quality approaches: ISO 9000, Malcolm Baldrige, and Six Sigma.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 615.19 NAL (Browse shelf(Opens below)) 1 Available 00214465

Includes bibliographical references and index.

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 -- 6.Control of compoents 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 and distribution: subpart H. Joseph D. Nally -- 10.Laboratory controls: subpart I. Wayne J. DeWitte and Alex M. Hoinowski -- 11.Records and reports: subpart J. Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura N. 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 ingredients. Irwin Silverstein -- 19.Recalls, warning lettters, seizures and injunctions: CGMP enforcement alternatives in the United States. Joseph D. Nally -- 20.Controlled substances safeguards. Joseph D. Nally -- 21.The inspectioin procedure for compliance in the United States: the regulatee is inspected: the rationale for inspection (21 USC 373, 374). Joseph D. Nally -- 23.Worldwide good manufacturing proactices. Joseph D. Nally -- 24.Quality approaches: ISO 9000, Malcolm Baldrige, and Six Sigma.

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