有关共线生产的国外法规有哪些?
QA

有关共线生产的国外法规有哪些?

提供相关法规的最新版?

国内相关法规有哪些?

2023-05-20 14:19 _清风明月     
3个回答

共线生产的法规,参见识林主题词“共线”,2.1为国内法规、2.2-2.6为国外法规。

2023-05-22 12:49 用户b0qx     

回答:

参考搜索识林“共线”,详见共线

2023-05-22 13:25 圣人有点冷     

希望可以帮到你:

1. CFDI 2023.03 药品共线生产质量风险管理指南

2. FDA 2013.04 Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

3. EMA 2014 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

4.  EMA 2018  Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based                             exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’

5. EU GMP Part1  有相关章节 

2023-05-22 15:14 匿名