000			03062cam a22004334a 4500
001			5754
003			BD-DhEWU
005			20180109132520.0
008			040507s2005 n a g b 001 0 eng
010			_a 2004050322
020			_a0849319943 (alk. paper)
020			_a 9780849319945
035			_a(OCoLC)
040			_aDLC _cDLC _dDLC _dBD-DhEWU _beng
041			_aeng
050	0	0	_aRS189 _b.S524 2005
082	0	0	_a615.362178273 _bSHG 2005 _222
100	1		_aSharp, John, _99012
245	1	0	_aGood pharmaceutical manufacturing practice : _brationale and compliance / _cJohn Sharp.
260			_aNew York : _bCRC Press, _cc2005.
300			_aix, 503 p. : _bill. ; _c26 cm.
504			_aIncludes bibliographical references and index.
505			_a 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. _tTOC
520			_aBridging 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.
526			_aPharmacy
590			_aAbdul Gani
650		0	_aDrugs _xStandards _zUnited States. _98752
650		0	_aDrugs _xStandards _zEuropean Union Countries. _99013
650		0	_aPharmaceutical industry _zUnited States _xQuality control. _99014
650		0	_aPharmaceutical industry _zEuropean Union Countries _xQuality control. _99015
650		0	_aDrugs _xLaw and legislation _zUnited States. _98534
650		0	_aDrugs _xLaw and legislation _zEuropean Union Countries. _99016
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0646/2004050322-d.html
856	4	2	_3WorldCat details _uhttp://www.worldcat.org/title/good-pharmaceutical-manufacturing-practice-rationale-and-compliance/oclc/55149519&referer=brief_results
856	4	0	_3E-book Fulltext _uhttp://lib.ewubd.edu/ebook/5754
942			_2ddc _cTEXT
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