Test Until Clean?

beiwei5du

这篇文章写道了大家“清洁至合格”的误解，其实很多法规（EU,FDA,CANADA HEALTH,PIC/S,WHO，具体见原文）明确规定不能“清洁至合格”的一个前提是在已验证的清洁规程的前提下，其实没有验证的清洁工艺或者不需要验证的清洁工艺，完全可以“清洁至合格”，通过清洁确认来判断。
具体有几个问题，望大家探讨：

1、Test Until Clean

Examine and evaluate the level of testing and the retest results since testing until clean is a concept utilized by some manufacturers. They test, resample, and retest equipment or systems until an "acceptable" residue level is attained. For the system or equipment with a validated cleaning process, this practice of resampling should not be utilized and is acceptable only in rare cases. Constant retesting and resampling can show that the cleaning process is not validated since these retests actually document the presence of unacceptable residue and contaminants from an ineffective cleaning process.

请问上面说的rare cases.是指什么情况下？？

2、I am also aware of companies who for routine manufacture, choose to perform cleaning verification on every batch of product. They could have chosen to perform cleaning validation, but decided that cleaning verificationon every batch was more appropriate for their situations. To those who might object to this practice, let’s remember the objective of both cleaning validation and cleaning verification – to produce equipment that canbe safely used for manufacture of the next product.

大家怎么认为这种行为？？？？同时cleaning veriication和cleaning validation的目的到底是什么？？？？

globle001

目的说很清楚了：to produce equipment that canbe safely used for manufacture of the next product.
大家怎么认为这种行为？？？
  不同公司有不同的策略，尤其是CMO公司可能Cleaning verification更合适，因为有几十到几百各化合物，CV不可能做得了。因为作者是站在很高层面去谈这个事情，但是目的是一样的。

beiwei5du

globle001 发表于 2017-9-2 22:23
目的说很清楚了：to produce equipment that canbe safely used for manufacture of the next product.
大 ...

但是cleaning verification和cleaning validation的保证程度不，这个应该基于本身的风险的客观评估来确定是否进行“cleaning verification”和“cleaning validation”，而不是基于主观的我想不想做就可以，所以个人认为上文举例的那种行为以实施“清洁至合格”是绝不可以的。cleaning verification在风险较高的情况下绝不能做到“to produce equipment that canbe safely used for manufacture of the next product.”。比如清洁中由于清洁工艺变动较大（改变清洗剂，改变温度时间等等），造成产生不能被检测到其他的高活性，高危害的物质，cleaning verification是完全不能做到检测的（这个和生产工艺验证是一个道理）。

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