WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-fifth report.
World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations Specifications for Pharmaceutical Preparations
- Geneva, Switzerland : World Health Organization, c2011.
- xii, 428 p. : ill. ; 24 cm.
- WHO Technical report series, 961 0512-3054 ; .
- Technical report series (World Health Organization) ; 961. .
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.
9789241209618
Drugs--Standards--Congresses.
Drugs--Specifications--Congresses.
Drugs--Quality control--Congresses.
Pharmacopoeias--Congresses.
Drug Industry--standards--Congresses.
Pharmaceutical Preparations--standards--Congresses.
Pharmacopoeias as Topic--Congresses.
Reference Standards--Congresses.
Quality Control--Congresses.
Congresses.
615.1 / W6282w
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.
9789241209618
Drugs--Standards--Congresses.
Drugs--Specifications--Congresses.
Drugs--Quality control--Congresses.
Pharmacopoeias--Congresses.
Drug Industry--standards--Congresses.
Pharmaceutical Preparations--standards--Congresses.
Pharmacopoeias as Topic--Congresses.
Reference Standards--Congresses.
Quality Control--Congresses.
Congresses.
615.1 / W6282w