000 02215nam a22002897i 4500
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_d4158
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003 PILC
005 20240720152448.0
008 160505b2006 xxu||||| |||| 00| 0 eng d
020 _a9241209372
040 _erda
_cFEU-NRMF MEDICAL LIBRARY
_beng
050 _aWHO RA 189 .W475 2006
110 _aWorld Health Organization
245 _aWHO Expert Committee on Specifications for Pharmaceutical Preparations :
_bfortieth report.
264 _aGeneva :
_bWorld Health Organization,
_c2006.
300 _ax, 461 pages : illustration ; 24 cm.
336 _aText
337 _aUnmediated
338 _aVolume
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.
521 _arohkeahkh
650 _aDrugs
_xQuality control
_vCongresses.
650 _aDrugs
_xStandards
_vCongresses.
650 _aPharmacopoeias
_vCongresses.
942 _2lcc
_cB3