000			02290nam a22002897i 4500
999			_c4168 _d4168
001			4176
003			PILC
005			20240720152448.0
008			160505b2009 xxu||||| |||| 00| 0 eng d
020			_a9789241209533
040			_erda _cFEU-NRMF MEDICAL LIBRARY _beng
050			_aWHO RS 189 .W475 2009
110			_aWorld Health Organization
245			_aWHO Expert Committee on Specifications for Pharmaceutical Preparations : _bForty-third report.
260			_aGeneva : _bWorld Health Organization, _c2009.
300			_ax, 461 pages : _billustration ; _c24 cm.
336			_atext _2rdacontent
337			_aunmediated _2rdamedia
338			_avolume _2rdacarrier
440			_aWHO Technical Report Series _n953 _x0512-3054
500			_aIncludes bibliographical references.
500			_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.
650			_aDrugs _xQuality control _vCongresses
650			_aDrugs _xStandards _vCongresses
650			_aPharmacopoeias _vCongresses
942			_2lcc _cRU