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WHO Expert Committee on Specifications for Pharmaceutical Preparations：thirty-fourth report.

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Bibliographic Details
Corporate Authors: World Health Organization.; WHO Expert Committee on Specifications for Pharmaceutical Preparations. 1994 Geneva, Switzerland) (Geneva, Switzerland))
Published: World Health Organization,
Publisher Address: Geneva
Publication Dates: 1996.
Literature type: Book
Language: English
Series: WHO technical report series ; 863
Subjects:
Drugs > Quality control.
Pharmacopoeias.
Pharmaceutical Preparations
Drugs > Standards.
Carrier Form: vi, 194 p.: ill. ; 24 cm.
ISBN: 9241208635 (pbk.)
Index Number: R9
CLC: R9-65
R951
Call Number: R951/W927/34th.rep.
Contents: "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 28, November 2, 2 December 1994"--P. v.
Includes bibliographical references.
Introduction -- The international pharmacopoeia and related activities -- Simple test methodology -- Stability of dosage forms -- Good manufacturing practices for pharmaceutical products -- Legal and administrative aspects of the functioning of national drug regulatory authorities -- Quality assurance in the supply system -- Terminology -- Acknowledgements -- References -- Annex 1 - guidelines for the graphic representation of chemical formulae -- Annex 2 - list of available International Chemical Reference Substances -- Annex 3 - list of available International Infrared Reference Specta -- Annex 4 - general recommendations for the preparation and use of infrared spectra in pharmaceutical analysis -- Annex 5 - guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms -- Annex 6 - good manufacturing practices: guidelines on the validation of manufacturing processes -- Annex 7 - good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans -- Annex 8 -good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products -- Annex 9 - multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability -- Annex 10 - guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce -- Annex 11 - guidelines for the assessment of herbal medicines -- Annex 12 - guidelines on import procedures for pharmaceutical products.

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