Good manufacturing practices for pharmaceuticals

Type Book

Rate 0.0 /5

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturi…

Details

Files

Reviews

Download

Title Statements

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

Summary

Edition Statements

Publication Date:©2007.
Edition:6th ed

Publication Statements

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

The Physical Object

Description:1 online resource (viii, 398 pages) : : illustrations

Edition Identifiers

ISBN:9781420020939, 1420020935
oclc:ocn164793904
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

BUSINESS & ECONOMICS -- Industries Drug Industry -- standards Drugs -- Standards Drugs -- Standards -- United States Electronic books 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