000			02927cam a2200457 a 4500
001			4428
003			BD-DhEWU
005			20171217115112.0
008			031029s2003 nyua g b 001 0 eng d
010			_a 2003279593
020			_a0824708385 (alk. paper)
020			_a9780824708382
035			_a(OCoLC)54001293
040			_aDLC _cDLC _dDLC _dBD-DhEWU _beng
041			_aeng
050	0	0	_aRS189 _b.P46 2003
082	0	4	_a615.1 _bPHA 2003
245	0	0	_aPharmaceutical process validation / _cedited by Robert A. Nash, Alfred H. Wachter.
250			_aInternational 3rd ed., rev. and expanded.
260			_aNew York : _bMarcel Dekker, _cc2003.
300			_axxxvi, 860 p. : _bill. ; _c24 cm.
490	1		_aDrugs and the pharmaceutical sciences ; _v129
504			_aIncludes bibliographical references and index.
505			_tTOC _aRegulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation.
520			_aThe third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends
526			_aPharmacy
590			_aSagar Shahanawaz
650		0	_aPharmaceutical industry _xQuality control. _91081
650		0	_aDrugs _xStandards _zUnited States. _98752
650		2	_aDrug Evaluation _xstandards _zUnited States. _916487
650		2	_aDrug Industry _xstandards _zUnited States. _916488
650		2	_aQuality Control. _916489
700	1		_aBerry, Ira R., _d1942- _98535
700	1		_aNash, Robert A., _d1930- _916490
830		0	_aDrugs and the pharmaceutical sciences ; _921401
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/2003279593-d.html
856	4	2	_3WorldCat details _uhttps://www.worldcat.org/title/pharmaceutical-process-validation/oclc/54001293&referer=brief_results
856	4	0	_3E-Book Fulltext _uhttp://lib.ewubd.edu/ebook/4428
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