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《制药机械(设备)验证导则》是实施药品生产质量管理规范活动中的一项急需的指导性标准,急需制定的原因,在于《药品生产质量管理规范》(GMP)规定对制药设备要进行产品和工艺验证;二是制药设备的验证正在成为药品生产企业衡量和评价制药机械产品质量、订货以及制造企业产品的市场认可方式。急需在行业内规范指导制药设备的验证活动,配合 GMP的贯彻实施。该标准经国家发展和改革委员会2005年立项制定,2007年第16号公告发布,于2007年9月1日起实施。
The Guidelines for the Validation of Pharmaceutical Machinery (Equipment) is a much needed guiding standard in the implementation of Good Manufacturing Practices (NQPs) and urgently needs to be drawn from the GMP requirements for pharmaceutical equipment Product and process validation; the second is the validation of pharmaceutical equipment is becoming a pharmaceutical manufacturing enterprises to measure and evaluate the quality of pharmaceutical machinery products, orders and manufacturing products recognized by the market means. Urgent need to guide the pharmaceutical equipment in the industry norms to verify the activities, with the implementation of GMP. This standard was promulgated by the National Development and Reform Commission in 2005 and released in Announcement No. 16 of 2007, which came into effect on September 1, 2007.