000			03033nam a2200409Ia 4500
001			EBC284686
003			MiAaPQ
005			20240120130210.0
006			m o d |
007			cr cn|||||||||
008			060721s2006 sz a sb i100 0 eng d
020			_z9241209372
035			_a(MiAaPQ)EBC284686
035			_a(Au-PeEL)EBL284686
035			_a(CaPaEBR)ebr10137826
035			_a(CaONFJC)MIL50329
035			_a(OCoLC)476034960
040			_aMiAaPQ _cMiAaPQ _dMiAaPQ
050		4	_aRA8 _b.A247 2006
245	0	0	_aWHO Expert Committee on Specifications for Pharmaceutical Preparations _h[electronic resource] : _bfortieth report.
260			_aGeneva : _bWorld Health Organization, _c2006.
300			_ax, 461 p. : _bill.
490	1		_aWHO technical report series ; _v937
500			_a"WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii.
504			_aIncludes bibliographical references.
520			_aThis report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
533			_aElectronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
650		0	_aDrugs _xStandards _vCongresses.
650		0	_aPharmacopoeias _vCongresses.
650		0	_aDrugs _xQuality control _vCongresses.
655		4	_aElectronic books.
710	2		_aWorld Health Organization.
710	2		_aWHO Expert Committee on Specifications for Pharmaceutical Preparations _n(40th : _d2005 : _cGeneva, Switzerland)
710	2		_aProQuest (Firm)
830		0	_aTechnical report series (World Health Organization) ; _v937.
856	4	0	_uhttps://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=284686 _zClick to View
999			_c27715 _d27715