Good pharmaceutical manufacturing practice : rationale and compliance (Book, 2005) [WorldCat.org]
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Good pharmaceutical manufacturing practice : rationale and compliance

Author: John Sharp
Publisher: Boca Raton, Fla. : CRC Press, ©2005.
Edition/Format:   Print book : EnglishView all editions and formats
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  Read more...
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Details

Document Type: Book
All Authors / Contributors: John Sharp
ISBN: 0849319943 9780849319945
OCLC Number: 55149519
Description: ix, 503 pages : illustrations ; 26 cm
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.
Responsibility: John Sharp.
More information:

Abstract:

"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."--Jacket.

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