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 |