医药工程C&Q项目

仗义凌然的蚂蚁 · 发表于 2021-2-25 19:24:38

欢迎您注册蒲公英

您需要登录才可以下载或查看，没有帐号？立即注册

x

这里的“C&Q”什么意思？请老师指点

光风霁月 · 发表于 2021-2-26 10:39:17

Commissioning & Qualification 调试与确认
医药工程C&Q项目一般涉及到制药生产设施，系统，公用系统，和设备的设计，施工和确认。
相关法规指南包括但不限于：EU GMP Annex 15 Qualification and Validation (2015)
                                       US FDA Guidance for Industry: Process Validation (2011)
                                       ICH Q9 Quality Risk Management (2005)
                                       ASTM E2500 - 20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
                                       ISPE Baseline Guide: Volume 5 - Commissioning and Qualification (1st Edition, 2001 and 2nd Edition, 2019)
                                       ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, System, and Equipment (2011)
                                       ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (2011)

茶客 · 发表于 2021-2-26 08:51:25

调试与确认

寻寻 · 发表于 2021-2-26 09:16:20

commissioning and qualification

好吧那就这样吧 · 发表于 2021-2-27 18:10:34

Commissioning & Qualification 调试与确认，现在已经出到第二版了

[工程设计] 医药工程C&Q项目

欢迎您注册蒲公英

浏览过的版块