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Good pharmaceutical manufacturing practice : rationale and compliance / John Sharp.

By: Sharp, John.
Material type: TextTextPublisher: New York : CRC Press, c2005Description: ix, 503 p. : ill. ; 26 cm.ISBN: 0849319943 (alk. paper); 9780849319945.Subject(s): Drugs -- Standards -- United States | Drugs -- Standards -- European Union Countries | Pharmaceutical industry -- United States -- Quality control | Pharmaceutical industry -- European Union Countries -- Quality control | Drugs -- Law and legislation -- United States | Drugs -- Law and legislation -- European Union CountriesDDC classification: 615.362178273 Online resources: Publisher description | WorldCat details | E-book Fulltext
Contents:
Introduction: status and applicability of US regulations/EU guidelines - general quality issues -- Personnel, organization, and training -- Premises/buildings and facilities -- Contamination and contamination control -- Equipment -- Materials control -- Production and process controls -- Packaging and labeling control -- Holding and distribution -- Laboratory controls -- Records and reports -- Returned and salvaged drug products -- Sterile products manufacture - basic principles -- GMP and quality assurance in sterile products manufacture -- Validation - general principles -- Validation - applications -- Self-inspection and quality audit -- US cGMPs and EC GMP guide - concluding comparison. Table of contents
Summary: Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices."--BOOK JACKET.
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Non-fiction 615.362178273 SHG 2005 (Browse shelf) Not for loan
Text Text EWU Library
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Non-fiction 615.362178273 SHG 2005 (Browse shelf) C-1 Not For Loan 21430
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Non-fiction 615.362178273 SHG 2005 (Browse shelf) C-2 Available 21431
Text Text EWU Library
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Non-fiction 615.362178273 SHG 2005 (Browse shelf) C-3 Checked out 17/12/2019 21432
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Includes bibliographical references and index.

Introduction: status and applicability of US regulations/EU guidelines - general quality issues --
Personnel, organization, and training --
Premises/buildings and facilities --
Contamination and contamination control --
Equipment --
Materials control --
Production and process controls --
Packaging and labeling control --
Holding and distribution --
Laboratory controls --
Records and reports --
Returned and salvaged drug products --
Sterile products manufacture - basic principles --
GMP and quality assurance in sterile products manufacture --
Validation - general principles --
Validation - applications --
Self-inspection and quality audit --
US cGMPs and EC GMP guide - concluding comparison. Table of contents

Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices."--BOOK JACKET.

Pharmacy

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