Good manufacturing practices for pharmaceuticals

by Nally, Joseph D. Willig, Sidney H.

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Title Statements

Full title :Good manufacturing practices for pharmaceuticals.

Edition Statements

Publication Date:©2007.
Edition:6th ed

Publication Statements

Publisher(s):Informa healthcare
Place of Publication:New York
Language:eng
Publication Date:©2007.

Notes

Revised edition of: Good manufacturing practices for pharmaceuticals / Sidney H. Willig. 5th ed., rev. and expanded.

The Physical Object

Description:viii, 398 pages : : illustrations.

Edition Identifiers

ISBN:9780849339721, 0849339723
oclc:ocm78051859
LC Classification:RS189
Dewey Decimal:338.4/76151

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 -- 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 /…

Subjects

Drug Industry -- standards Drugs -- Standards Drugs -- Standards -- United States Industrie pharmaceutique -- Qualité Legislation, Drug Médicaments -- Normes -- États-Unis Pharmaceutical industry -- Quality cont… Pharmaceutical Preparations -- standards Qualité -- Contrôle Quality control Technology, Pharmaceutical -- standards United States