Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed
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manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of
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pharmaceutical management, with each topic being covered by a subset of indicators. Thirty-four of the indicators are quantitative, that is, expressed as numbers. Twelve are qualitative, in that they describe the presence or absence of a policy or management system, and in some cases, the degree of implementation.
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Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
English version - This handbook sets out a the new paradigm for pharmacy practice. Its aim is to guide pharmacy educators in pharmacy practice, to educate pharmacy students and to guide pharmacists in practice to update their skills. The handbook, which brings together practical tools and knowledge,
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has been written in response to a need to define, develop and generate global understanding of pharmaceutical care at all levels.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.