WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-third report.
WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-third report.
- Geneva : World Health Organization, c2009.
- xi, 161 p. ; 24 cm.
- Technical report series (World Health Organization), 953 0512-3054 ; .
- Technical report series (World Health Organization) ; 953 .
The WHO Expert Committee met in Geneva from October 13-17, 2008.
Includes bibliographical references.
Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- Quality control : specifications and tests -- Quality control -- International Reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) -- Quality control -- National laboratories -- Quality assurance -- Good manufacturing practices -- Quality Assurance -- new approaches and risk analysis -- Quality assurance -- distribution and trade of pharmaceuticals -- Quality assurance -- stability -- Prequalifi cation of priority essential medicines and devices -- Prequalifi cation of quality control laboratories -- Prequalifi cation of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Miscellaneous -- Summary and recommendations
9789241209533 9241209534 9241209488 9789241209489
2009366336
Drugs--Standards.
Pharmacopoeias.
Drugs--Quality control.
Pharmaceutical Preparations--standards--Congresses.
Pharmacopoeias as Topic--Congresses.
Reference Standards--Congresses.
RS189 / .W475 2009
615/.1
The WHO Expert Committee met in Geneva from October 13-17, 2008.
Includes bibliographical references.
Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- Quality control : specifications and tests -- Quality control -- International Reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) -- Quality control -- National laboratories -- Quality assurance -- Good manufacturing practices -- Quality Assurance -- new approaches and risk analysis -- Quality assurance -- distribution and trade of pharmaceuticals -- Quality assurance -- stability -- Prequalifi cation of priority essential medicines and devices -- Prequalifi cation of quality control laboratories -- Prequalifi cation of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Miscellaneous -- Summary and recommendations
9789241209533 9241209534 9241209488 9789241209489
2009366336
Drugs--Standards.
Pharmacopoeias.
Drugs--Quality control.
Pharmaceutical Preparations--standards--Congresses.
Pharmacopoeias as Topic--Congresses.
Reference Standards--Congresses.
RS189 / .W475 2009
615/.1