实施GMP的中心指导思想是什么?

2023-04-17 · 法默康

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实施GMP的中心指导思想是什么?封面图

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实施GMP的中心指导思想是:任何药品质量的形成是设计出来的,而不是检验出来的,为了贯彻这个中心思想,必须要做到:

The central guiding ideology of implementing GMP is that the formation of any drug quality is designed, not tested. In order to implement this central ideology, it is necessary to:

⑴相对固定主要原辅料、包装材料采购的供应商,坚持对供应商的质量评估。

(1) Suppliers who purchase relatively fixed main raw and auxiliary materials and packaging materials should adhere to quality evaluation of suppliers.

⑵厂区按功能和防污染的原则进行规划。

⑵ The factory area is planned based on the principles of functionality and pollution prevention.

⑶厂房生产要求合理布局,避免污染与交叉污染,达到规定的洁净要求。

⑶ The production of the factory requires a reasonable layout to avoid pollution and cross contamination, and to meet the specified cleanliness requirements.

⑷制药设备合理配置,尽可能采用先进设备和智能化设备淘汰生产中易造成污染与交叉污染的设备与设施。

(4) Reasonable configuration of pharmaceutical equipment, using advanced and intelligent equipment as much as possible to eliminate equipment and facilities that are prone to pollution and cross contamination in production.

⑸一切工作文件化。真正使文件成为企业的“法律”,反对抄袭、照搬硬套和执行文件坡走过场或视文件为装饰品。

(5) Document all work. To truly make documents the "law" of enterprises, and to oppose plagiarism, copying hard copies, and the use of documents as decorations.

⑹规范各种操作

(6) Standardize various operations

⑺质量管理严格要求。实行三级质量管理体系,完善质量评估制度,监督制度和报告制度,不断提高药品标准水平。

(7) Strict quality management requirements. Implement a three-level quality management system, improve the quality evaluation system, supervision system, and reporting system, and continuously improve the level of drug standards.

⑻验证工作科学化。

(8) Scientific validation work.

⑼人员培训制度化。

Institutionalize personnel training.

⑽卫生工作经常化。

Regularization of health work.

⑾完善售后服务,及时报告药品重大质量事故与不良反应,使药品质量处于严密的监督控制之中,防患于未然。

(11) Improve after-sales service, timely report major quality accidents and adverse reactions of drugs, and ensure that drug quality is under strict supervision and control to prevent potential problems.