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一个协会在促进药品质量保证方面的作用:基于伙伴制度的技术诀窍转移

[Role of an association in promoting pharmaceutical quality assurance: transfer of know-how based on the buddy system].

作者信息

Ba A, Courcambeck A, Degui H

机构信息

Centrale humanitaire medico-pharmnaceutique, Clermont Ferrand, France.

出版信息

Med Trop (Mars). 2006 Dec;66(6):538-41.

PMID:17286016
Abstract

The pharmaceutical world is undergoing rapid and radical changes with increasing complexity. Countries with limited resources are particularly powerless faced to these changes that have had a particularly strong impact on their pharmaceutical systems. To achieve the level of performance required to ensure continuous supplies of quality pharmaceutical products, pharmaceutical systems must be organized on the basis of quality assurance principles that use change as a motor of development. Implementation of quality assurance schemes provides management tools for gathering and processing the information necessary to develop an infrastructure satisfying the demand for quality medicines. Organization of such systems must be based on process improvement. In this framework, associations specialized in such pharmaceutical quality assurance can play a special role. The Medico-Pharmaceutical Humanitarian Group (French acronym, CHMP) is a humanitarian association that provides personnel for development and action in health-related products. The mission of the CHMP is to assist procurement and distribution structures in developing countries to achieve sustainable development by transfer of technical know-how.

摘要

制药行业正在经历快速而彻底的变革,复杂性日益增加。资源有限的国家在面对这些对其制药系统产生特别强烈影响的变革时尤其无能为力。为达到确保持续供应优质药品所需的绩效水平,制药系统必须基于将变革作为发展动力的质量保证原则来组织。质量保证计划的实施提供了管理工具,用于收集和处理开发满足优质药品需求的基础设施所需的信息。此类系统的组织必须基于流程改进。在此框架内,专门从事此类药品质量保证的协会可以发挥特殊作用。医药人道主义组织(法语首字母缩写,CHMP)是一个人道主义协会,为与健康相关产品的开发和行动提供人员。CHMP的使命是通过技术诀窍的转移,协助发展中国家的采购和分销结构实现可持续发展。

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