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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.



ISBN: 9789241209618 9241209615

LCCN: 2011293946

Subjects--Topical Terms:
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.

Index Terms--Genre/Form:
Congresses.

LC Class. No.: RS189 / .W4753 2011

Dewey Class. No.: 615.1

National Agricultural Library Call No.: RA189 / .W55 2011

National Library of Medicine Call No.: WA16 / W676t no.961 2011