中成药质量溯源系统建设方案的研究与实现

Research and implementation of the construction scheme for the quality traceability system of Chinese patent medicine

对中成药生产进行规范化管理,实行药品的全生命周期质量监管已日益迫切。文章介绍了中成药质量溯源系统的建设方案,运用信息化技术,实现中药材种植、采收、加工以及生产成品和药品销售的全生命周期的电子化管理,从而形成来源可追溯、去向可查证、责任可追究的质量安全追溯体系。

It is urgent to standardize the management of Chinese patent medicine and implement the whole life cycle quality control of the drugs. This paper describes the construction scheme for the quality traceability system of Chinese medicine products,which uses information technology to achieve the electronic management during the entire life cycle of Chinese patent medicine,including the traditional Chinese medicinal materials planting, harvesting, processing and producing of finished products and pharmaceutical sales, so as to form a quality and safety traceability system, by which the source can be traced, the whereabouts can be verified, and the responsibility can be investigated.