TY  - BOOK
AU  - Nally,Joseph D.
TI  - Good manufacturing practices for pharmaceuticals
T2  - Drugs and the pharmaceutical sciences,
SN  - 9780849339721
AV  - RS189 .W57 2007
U1  - 615.19 NAL 
PY  - 2007///
CY  - New York, NY
PB  - Informa Healthcare
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Drugs
KW  - Standards
KW  - United States
KW  - Pharmaceutical Preparations
KW  - standard
KW  - Drug Industry
KW  - Legislation, Drug
KW  - Quality Control
KW  - Technology, Pharmaceutical
KW  - Pharmaceutical chemistry & technology
KW  - thema
KW  - Manufacturing industries
N1  - 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
ER  -