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-fifth report
T2  - WHO Technical report series,
SN  - 9789241209618
AV  - RS189 .W4753 2011
U1  - 615.1 
PY  - 2011///
CY  - Geneva, Switzerland
PB  - World Health Organization
KW  - Drugs
KW  - Standards
KW  - Congresses
KW  - Specifications
KW  - Quality control
KW  - Pharmacopoeias
KW  - Drug Industry
KW  - standards
KW  - Pharmaceutical Preparations
KW  - Pharmacopoeias as Topic
KW  - Reference Standards
KW  - Quality Control
N1  - The WHO Expert Committee met in Geneva from October 18-22, 2010; 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 -- Quality assurance: distribution and trade of pharmaceuticals -- Prequalification of priority essential medicines -- Prequalification of quality control laboratories -- Prequalification of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Summary and recommendations -- Annexes; Also available via World Wide Web
UR  - http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
ER  -