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Comité OMS d' experts des spécifications relatives aux préparations pharmaceutiques [réuni à Genève du 4 au 9 novembre 1974] : vingt-cinquième rapport
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1975 )
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Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas [se reuni'o en Ginebra del 14 al 19 de octubre de 1968] : 22o informe
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1969 )
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Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas [se reuni'o en Ginebra del 5 al 10 de diciembre de 1983] : 29o informe
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting ( 1984 )
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Comité OMS d' experts des spécifications relatives aux préparations pharmaceutiques [réuni à Genève du 3 au 9 novembre 1964] : vingt et unième rapport
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1965 )
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Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas [se reuni'o en Ginebra del 26 de abril al 1 de mayo de 1971] : 24o informe
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1972 )
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WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 5 to 10 December 1983] : twenty-ninth report
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1984 )
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WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 30 November to 4 December 1992] : thirty-third report
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1993 )
Abstract

A progress report on a number of WHO-sponsored activities designed to support a comprehensive approach to the quality assurance of pharmaceutical products. Topics discussed include the continuing development of The International Pharmacopoeia, the establishment of International Chemical Reference Substances and International Infrared Reference Spectra, and the problem of substandard quality of several widely used drug substances. The report also issues recommendations concerning the small-scale preparation of eye drops, and a warning concerning the production of oral and injectable hormonal contraceptives in the absence of well established local programmes of drug regulation and quality assurance. Annexed to the report are guidelines for good manufacturing practices for biological products and up-dated lists of available Chemical Reference Substances and International Infrared Reference Spectra

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WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 10 to 15 December 1990] : thirty second report
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1992 )
Abstract

Issues five sets of detailed guidelines intended to assist drug regulatory authorities in implementing a rigorous, comprehensive system for the quality control of pharmaceutical products. Focused on key components in a national system for quality assurance, the guidelines set out up-to-date principles, procedures, standards and requirements that can assist both regulators and manufacturers in their efforts to control the safety, quality, potency, and efficacy of pharmaceutical products The first and most extensive guidelines present updated requirements for good manufacturing practices in pharmaceutical production. The requirements, which are presented in three main parts, have been considerably revised and expanded from the 1975 version to reflect advances in pharmaceutical manufacturing technology. Part one outlines the general concepts and essential elements of quality assurance in the production of pharmaceuticals. The second part, on good practices in production and quality control, offers guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance. The third part sets out supplementary guidelines for the manufacture of sterile preparations and the production of active pharmaceutical ingredients. The second guidelines provide a step-by-step description of the procedures to be followed during the inspection of pharmaceutical manufacturing facilities in order to ascertain adherence to good manufacturing practices. The third guidelines cover implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, which has also been revised and considerably strengthened. To make the certification procedures better suited to rigorous control, particularly in view of the increasingly numerous reports of substandard and counterfeit drugs found on the market in developing countries, three different forms of attestation are proposed. Additional guidelines cover the quality of pharmaceutical and biological products prepared by recombinant DNA technology, and the validation of analytical procedures used in the examination of pharmaceutical products to ensure safety and efficacy at all stages of shelf-life, including storage, distribution and use. The remaining sections provide updated lists of available international chemical reference substances and of adopted international infrared reference spectra, and outline a protocol for a study on the quality of selected drugs at the point of use in developing countries

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Comité OMS d' experts des spécifications relatives aux préparations pharmaceutiques [réuni à Genève du 25 au 30 avril 1977] : vingt-sixième rapport
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1977 )
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WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 28 November to 3 December 1988] : thirty-first report
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting; World Health Organization ( 1990 )
Abstract

Considers questions concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Technical issues discussed include drug stability and sampling procedures, the problems created by falsely labelled, spurious, counterfeited, and substandard preparations, and the corresponding need for appropriate preventive measures in both importing and exporting countries. Other topics include the further development of the International Pharmacopoeia, the establishment of international chemical reference substances, and developments in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Annexed to the report is a document outlining guiding principles for small national drug regulatory authorities