000			02245cam a2200409 i 4500
999			_c2113 _d2113
001			13387640
005			20200916142022.0
008			031029s2003 nyua b 001 0 eng
020			_a0824708385 (alk. paper)
040			_aDLC _cDLC _dDLC _erda
043			_an-us---
082	0	0	_a615.10685 _222 _bP
245	0	0	_aPharmaceutical process validation / _cedited by Robert A. Nash, Alfred H. Wachter.
250			_aInternational Third edition, revised and expanded.
264		1	_aNew York : _bMarcel Dekker, _c[2003]
300			_axxxvi, 860 pages : _bIllustrations ; _c24 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
490	1		_aDrugs and the pharmaceutical sciences ; _v129
504			_aIncludes bibliographical references and index.
505			_aPreface -- Contents -- Contributors -- Introduction -- Regulatory 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 Pharmaceutical Ingredients -- Qualification of Water and Air Handling Systems -- Equipment and Facility Qualification -- Validation and Verification of Cleaning Processes.
650		0	_aPharmaceutical industry _xQuality control.
650		0	_aDrugs _xStandards _zUnited States.
650		2	_aDrug Evaluation _xstandards _zUnited States.
650		2	_aDrug Industry _xstandards _zUnited States.
650		2	_aQuality Control.
700	1		_aBerry, Ira R., _d1942- _98640 _eeditor.
700	1		_aNash, Robert A., _d1930- _98641 _eeditor.
830		0	_aDrugs and the pharmaceutical sciences ; _vv. 129. _98642
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/2003279593-d.html
856	4	2	_3Abstract _uhttp://repository.fue.edu.eg/xmlui/handle/123456789/1547
906			_a7 _bcbc _corigcop _d2 _encip _f20 _gy-gencatlg
942			_2ddc _cBK