清洁验证中为什么需要包括最差操作条件

beiwei5du

各位蒲友：
清洁验证中为什么需要包括最差操作条件？？？为什么不能像生产工艺验证一样，纳入到第一阶段cleaning process design and development中去？？？
下文选自：PDA TR29 CLEANING VALIDATION

jaysun

因为实验室条件很难完全模拟实际情况，除非你能充分证明等同性

beiwei5du

jaysun 发表于 2017-9-16 22:14
因为实验室条件很难完全模拟实际情况，除非你能充分证明等同性

你的这个回复可能不正确，因为工艺验证的PPQ阶段局不需要考虑worst case process condition的挑战（注：这里说的worst case process condition是指normal operation parameter range内的最差条件）
PDA TR 29这个说法不知道是不是说错了？？或者还是其所说的cleaning validation是否包已经括3个阶段。其实其在前期的文章中就都说到了清洁验证的PPQ（第二阶段）中不需要进行相关的worst case process condition的挑战的了！仅供参考！

whb稻草

在清洁方法的设计与开发中纳入最差条件，到头来也需要来证明他的设计初衷，还是要验证的。

素粥一碗

工艺验证、清洁验证不同的参数达到的结果是不一样的。工艺参数超标不一定产品质量不符合要求。

whb稻草

素粥一碗 发表于 2017-9-17 10:51
工艺验证、清洁验证不同的参数达到的结果是不一样的。工艺参数超标不一定产品质量不符合要求。

？给我整蒙了……什么情况

beiwei5du

4.2.3   Worst-Case Process Conditions
The traditional approach for cleaning validation protocols has been to include worst-case process
conditions in the three protocol runs. Rationales for worst-case conditions should be given in or refer-
enced in the protocol. For example, worst-case process conditions may include maximum dirty hold
time, maximum batches or elapsed time in a campaign, shortest allowed time for manual cleaning
steps, lowest allowed temperature for manual cleaning processes, and worst-case circuits for CIP skid
selection. Parameters such as temperature, cleaning agent concentration, flow rates, and process step
times for  automated  cleaning processes are generally controlled in a  narrow  range such that challeng -
ing the cleaning process in the validation runs at the lower or upper end of  the specification is not
appropriate. If  those narrowly controlled parameters are to be challenged in the extremes or outside
the specified range, those challenges can be evaluated in development studies to demonstrate the
robustness of  the cleaning process.
There may be different approaches for addressing worst-case process conditions. In one approach,
a worst-case process condition is addressed in each of  the required validation runs. An alternative
approach is to address a specific worst-case condition in the design and development of  the cleaning
process such that the cleaning process is developed to address a worst-case condition. Data from such
design and development studies may support the use of  worst-case conditions in fewer runs.
Another example of  worst-case conditions is the number of  batches in a campaign where validated
cleaning is only performed at the end of  campaign. In such cases, there may be no cleaning between
batches or there may be only “minor cleaning” (such as vacuuming for solids manufacture or a wa-
ter rinse for liquids manufacture). In this case, the maximum number of  batches may represent the
worst case. Therefore, the validation protocol should consider the effect of  the maximum number of  
batches in the campaign.

jaysun

beiwei5du 发表于 2017-9-16 22:54
你的这个回复可能不正确，因为工艺验证的PPQ阶段局不需要考虑worst case process condition的挑战（注： ...

如果研发阶段用的一样的设备和公用设施，可以等同考虑，但是要给出理由，并且有质量控制批准最终报告，不一样设备和公用设施就很难说了，研发转移到生产通常会扩大化的，罐大小不同，表面积不同，管路管径不同，证明等同性比较难