000 01585nam a2200205Ia 4500
003 NULRC
005 20250520100709.0
008 250520s9999 xx 000 0 und d
020 _a9789241209434
040 _cNULRC
050 _aRS 51 .W67 2007
245 0 _aWHO Expert Committee on specifications for pharmaceutical preparations :
_bforty-first report.
260 _aGeneva, Switzerland :
_bWorld Health Organization,
_cc2007
300 _aiii, 156 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 and trade related -- Quality assurance- risk analysis -- Quality assurance- Stability -- Prequalification -- Regulatory guidance -- Nomenclature and computerized systems -- Miscellaneous -- Summary and recommendations
520 _aThis report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier.
650 _aDRUGS QUALITY CONTROL
942 _2lcc
_cBK
999 _c11716
_d11716