WHO Expert Committee on Specifications for Pharmaceutical Preparations:thirty-fourth report.
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Corporate Authors: | ; |
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Published: |
World Health Organization,
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Publisher Address: | Geneva |
Publication Dates: | 1996. |
Literature type: | Book |
Language: | English |
Series: |
WHO technical report series ; 863 |
Subjects: | |
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. |