000 01750nam a2200193Ia 4500
003 NULRC
005 20250520103024.0
008 250520s9999 xx 000 0 und d
020 _a9789241209922
040 _cNULRC
050 _aRA 8 .W67 2015
245 0 _aWHO Expert committee on specifications for pharmaceutical preparations :
_bforty-ninth report.
260 _aGeneva, Switzerland :
_bWorld Health Organization,
_cc2015
300 _axi, 210 pages ;
_c24 cm.
505 _a1. Introduction -- 2. General policy -- 3. Quality control - specifications and tests -- 4. Quality control - international reference materials (International Chemical Reference Substances and Infrared Reference Spectra) -- 5. Quality control - national laboratories -- 6. Quality assurance - good manufacturing practices -- 7. Quality assurance - new initiatives -- 8. Quality assurance - distribution and trade of pharmaceuticals -- 9. Prequalification of priority essential medicines -- 10. Prequalification of active pharmaceutical ingredients -- 11. Prequalification of quality control laboratories -- 12. Regulatory guidance -- 13. Nomenclature, terminology and databases -- 14. Miscellaneous -- 15. Summary and recommendations.
520 _aThe WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO.
650 _aDRUGS LAW AND LEGISLATION
942 _2lcc
_cBK
999 _c21590
_d21590