000			02442nam a2200205Ia 4500
003			NULRC
005			20250520100709.0
008			250520s9999 xx 000 0 und d
020			_a9789241209373
040			_cNULRC
050			_aRS 51 .W67 2006
245		0	_aWHO Expert Committee on specifications for pharmaceutical preparations : _bfortieth report.
260			_aGeneva, Switzerland : _bWorld Health Organization, _cc2006
300			_aiii, 461 pages ; _c24 cm.
504			_aIncludes bibliographical references.
505			_aIntroduction -- General Policy -- Quality control- specifications and tests -- Quality control- international Reference Materials -- Quality control- national laboratories -- Quality assurance- Good Manufacturing Practices -- Quality assurance- inspection -- Quality assurance- distribution -- Quality assurance- risk analysis -- Quality assurance- stability -- Prequalification -- Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products -- Donations of medicine
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.
650			_aDRUG QUALITY CONTROL
942			_2lcc _cBK
999			_c11717 _d11717