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    079527

    WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report.

    World Health Organization [WHO]. Expert Committee on Specifications for Pharmaceutical Preparations

    WORLD HEALTH ORGANIZATION TECHNICAL REPORT SERIES. 1992; (823):i-vi, 1-134.

    The WHO Expert Committee on Specifications for Pharmaceutical Preparations reports that several national and regional drug regulatory authorities have adopted guidelines for good manufacturing practices for drugs similar to those recommended by the Committee. Annex 1 discusses these practices and makes up most of the Committee's 32nd report. The report also presents provisional guidelines on inspection of pharmaceutical manufacturers. It reviews the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. The Committee-endorsed scheme depends on a more effective exchange of information to more rigorously control all international trade of pharmaceuticals. Chapter 6 looks at the international pharmacopoeia and related activities, including quality specifications for drug substances and dosage forms, validation of analytical procedures, a simple test methodology, national laboratories for drug surveillance and control, and quality control of products derived from medicinal plants. The report discusses and lists the International Chemical Reference Substances and International Infrared Reference Spectra. it also addresses stability of dosage forms and extemporaneous preparations. Annex 4 presents guidelines to guarantee the quality of pharmaceutical and biological drugs prepared by recombinant DNA technology. Another annex looks at validation of analytical procedures used to examine pharmaceutical materials. The last annex discusses the protocol for a proposed study on the quality of some drugs at the point of use in developing countries. WHO has already asked Benin, Guinea, Mozambique, Uganda, and Tanzania in Africa, Bangladesh and Myanmar in Asia, and Guatemala and Peru in the Americas to participate.
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