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一、背景及现状GMP是《药品生产质量管理规范》(Good Manufacture Practice)的缩写,是药品生产和质量管理的基本准则。GMP所规定的内容,是食品药品加工企业必须达到的最基本的条件。从2004年7月1日起,我国药品制剂和原料药已全部实现在GMP条件下生产。并且要求所有药品生产企业只有通过GMP认证,方可组织生产和销售产品。因此,GMP证书属于制药行业的准入证。
I. Background and Status GMP is an abbreviation of “Good Manufacture Practice” and is the basic guideline for pharmaceutical production and quality management. GMP provisions of the content, food and drug processing enterprises must meet the most basic conditions. From July 1, 2004 onwards, China’s pharmaceutical preparations and APIs have all been manufactured under GMP conditions. And requires that all drug manufacturers only through GMP certification, can organize the production and sale of products. Therefore, GMP certificate belongs to the pharmaceutical industry access card.