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    802203

    WHO Expert Committee on specification for pharmaceutical preparations: twenty-seventh report.

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

    Geneva, Switzerland, WHO, 1980. (WHO Technical Report Series No. 645)

    In this report of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparation, focus is on the following: 1) quality assurance in pharmaceutical supply systems; 2) revisions of the International Pharmacopoeia (methods of drug analysis, monographs for pharmaceutical raw materials, monographs for dosage forms, monographs for pharmaceutical aids); 3) international chemical reference substances for pharmaceuticals (reports from the WHO Collaborating Center, certificates, secondary reference substances, international cooperation, revision of guidelines); 4) quality requirements for oral dosage forms (tests for solid oral dosage forms, tests for liquid oral dosage forms, guidelines for in-process control of the manufature of some types of dosage forms); and 5) basic tests (basic tests for pharmaceutical substances, simple tests for the absence of gross degradation, basic tests for tablets and capsules, publication of basic tests). The Committee concluded that the term "quality assessment" was appropriate to the activities of governmental agencies who have been authorized to assess by inspection, surveillance and other means how closely manufacturers and distributers comply with drug quality requirements. Manufacturers are considered fully responsible for the quality of their products.
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