【请教】药品生产车间是否可以生产非药品？
发布于 2009-07-31 · 浏览 1.3 万 · IP 海南海南
这个帖子发布于 15 年零 285 天前，其中的信息可能已发生改变或有所发展。
推荐EU和WHO的GMP中均明确要求非药品（包括保健食品）与药品不能共用生产车间、共用生产设备生产，原文如下：
* 5.17 Normally, the production of non-medicinal products should be avoided in areas and with the equipment destined for the production of medicinal products. -- Chapter 5 Production, Part I - Basic Requirements for Medicinal Products, EudraLex - Volume 4, Good manufacturing practice (GMP) Guidelines.
* 16.8 Normally, non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products. -- Good Manufacturing Practices for Pharmaceutical Products: Main Principle (Annex 4, WHO Technical Report Series 908, 2003).
请问FDA有无类似规定？
* 5.17 Normally, the production of non-medicinal products should be avoided in areas and with the equipment destined for the production of medicinal products. -- Chapter 5 Production, Part I - Basic Requirements for Medicinal Products, EudraLex - Volume 4, Good manufacturing practice (GMP) Guidelines.
* 16.8 Normally, non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products. -- Good Manufacturing Practices for Pharmaceutical Products: Main Principle (Annex 4, WHO Technical Report Series 908, 2003).
请问FDA有无类似规定？
最后编辑于 2022-10-09 · 浏览 1.3 万
22 12 2
