TY  - BOOK
ED  - World Health Organization.
ED  - WHO Expert Committee on Specifications for Pharmaceutical Preparations
TI  - WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-third report
T2  - Technical report series (World Health Organization),
SN  - 9789241209533
AV  - RS189 .W475 2009
U1  - 615/.1 22
PY  - 2009///
CY  - Geneva
PB  - World Health Organization
KW  - Drugs
KW  - Standards
KW  - Pharmacopoeias
KW  - Quality control
KW  - Pharmaceutical Preparations
KW  - standards
KW  - Congresses
KW  - Pharmacopoeias as Topic
KW  - Reference Standards
N1  - 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; Available both in print and online
UR  - http://www.who.int/medicines/publications/pharmprep/PDF_TRS953_WEB.pdf
ER  -