TY  - BOOK
TI  - WHO Expert committee on specifications for pharmaceutical preparations: forty-ninth report
SN  - 9789241209922
AV  - RA 8 .W67 2015 
PY  - 2015///
CY  - Geneva, Switzerland
PB  - World Health Organization
KW  - DRUGS LAW AND LEGISLATION
N1  - 1. 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
N2  - The 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
ER  -