Good pharmaceutical manufacturing practice : rationale and compliance / John Sharp.
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TextLanguage: English Publication details: New York : CRC Press, c2005. Description: ix, 503 p. : ill. ; 26 cmISBN: 0849319943 (alk. paper); 9780849319945Subject(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 LOC classification: RS189 | .S524 2005Online resources: Publisher description | WorldCat details | E-book Fulltext | Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
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| 615.321 QUA 1998 Quality control methods for medicinal plant materials / | 615.3210951 MED 1989 Medicinal plants in China : | 615.321096 MED 1989 Medicinal plants in Viet Nam / | 615.362178273 SHG 2005 Good pharmaceutical manufacturing practice : | 615.372 QUV 2004 Vaccines : | 615.403 ENC 2003 Encyclopedia of clinical pharmacy / | 615.5 WEB 2010 Brody's human pharmacology : |
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. TOC
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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