清洁验证后的日常监测为什么要用清洁验证中的方法？

beiwei5du

为什么中国GMP要求“清洁验证后的日常监测必须使用验证中设定的检测方法”呢？？？？

中国GMP附录2 原料药
（七）清洁操作规程经验证后应当按验证中设定的检验方法定期进行监测，保证日常生产中操作规程的有效性

Q7A/EU
12.76 Cleaning procedures should be monitored at appropriate intervals after validation to ensure that these procedures are effective when used during routine production. Equipment cleanliness can be monitored by analytical testing and visual examination, where feasible. Visual inspection can allow detection of gross contamination concentrated in small areas that could otherwise go undetected by sampling and/or analysis.

美国Validation of Cleaning Processes (7/93)

• Routine Production In-Process Control
  
  Monitoring - Indirect testing, such as conductivity testing, may be of some value for routine monitoring once a cleaning process has been validated. This would be particularly true for the bulk drug substance manufacturer where reactors and centrifuges and piping between such large equipment can be sampled only using rinse solution samples. Any indirect test method must have been shown to correlate with the condition of the equipment. During validation, the firm should document that testing the uncleaned equipment gives a not acceptable result for the indirect test.
  
  
  

加拿大Cleaning Validation Guidelines (GUIDE-0028)
9.4 Indirect testing such as conductivity and TOC testing may be of some value for routine monitoring once a cleaning process has been validated. This could be applicable to reactors or centrifuge and piping between such large equipment can be sampled only using rinse solution samples.


图片选自： 2001 Human Drug CGMP Notes
https://www.gmp-navigator.com/guidemgr/files/vol9_nr2_human_drugs_cgmp_notes.pdf

yuansoul

我不打算 跟 煎茶员 抬杠。

beiwei5du

皇牌吐槽王 发表于 2017-9-8 20:45
日常监测也可以用其他方法，只要与你清洁验证中的检测方法建立关联即可。

需要理解的是：不是和清洁验证中的检测方法建立关联，而是与清洁工艺建立关联！！！！需要理解日常监测的目的！！！！

wwd7212

这个好像不是值得疑问的

beiwei5du

wwd7212 发表于 2017-9-9 08:12
这个好像不是值得疑问的

为什么？

yr98765

因为你验证的就是那个方法啊

yes850

当然是验证什么方法用什么方法了，这还有疑问吗

xqliu

用证明过的比较稳妥

beiwei5du

yes850 发表于 2017-9-9 15:36
当然是验证什么方法用什么方法了，这还有疑问吗

这是国人的误解啊！

beiwei5du

xqliu 发表于 2017-9-10 08:06
用证明过的比较稳妥

稳妥是稳妥，不科学！就像制定清洁限度，追求最低，但不科学！