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“优良生产操作规程”(Good Manufacturing Practice或称Good Practice in the Manufacture and Quality Control of Drugs,均缩写为GMP)亦可译为“药品优良生产和质量控制规范”,其中心目的是保证药品自原料进厂经过生产、工艺、检验、包装及储存以至成品出厂等环节都要符合安全、有效、质优、稳定及卫生的要求GMP不仅联合世界卫生组织(WHO)曾制订和发布此文件(参阅本刊1983年第3期P.74的全文介绍),供世界各国的参考实施,就是许多会员国也很重视,分别制定本国适用的GMP。我国在今年7月1日生效的(《药品管理法》中也明确规定药品生产企业必须按照卫生行政部门制定的《药品生产质量管理规范》的要求执行。本文针对GMP中的核心问题—卫生要求,如何具体去操作和完成,逐条地、详细地提出一些行之有效的措施和方法,很值得参考应用。
Good Manufacturing Practice or Good Practice in the Manufacture and Quality Control of Drugs (both abbreviated as GMP) can also be translated as “Good Manufacturing Practice for Pharmaceuticals and Quality Control”, the central purpose of which is to ensure that medicines are prepared from raw materials Import, production, processing, inspection, packaging and storage, as well as the delivery of finished products must comply with the requirements of safety, effectiveness, quality, stability and hygiene. Not only has GMP developed and published this document jointly with the World Health Organization (see Issue 3, 1983, p. 74), a reference for all countries in the world, is that many Member States attach great importance to the development of their respective national GMPs. China entered into force on July 1 this year (“Drug Administration Law” also clearly stipulates that the pharmaceutical manufacturing enterprises must be in accordance with the health administrative departments to develop “drug production quality management practices.” This article focuses on the GMP in the core issues - health requirements , How to operate and finish concretely, put forward some effective measures and methods one by one in detail, it is worth to consult application.