Dear all
Can anyone tell me the definition of the three consecutive batch for the CV?
If there is some minor cleaning between the major cleaning, will those two major cleaning can be seen as two consecutive batch for the CV? Therefore, in this way, maybe I will finish the CV after maybe 15 lots of batch, if I have four or five lots of minor cleaning in between each major cleaning. thank you
Hello coket,
I am no expert on CV but i will give my opinion based on what I have seen and my knowledge.
When we say three consecutive batches, we mean three batches separated only by one CV i.e,., major cleaning in your case. The minor validation cannot and should not interrupt this chain of validation activity.
You cannot finish CV after 15 lots of batch. but after 3 lots of batch.
waiting for other users opinion on this matter.
Thank you Yogibear
Because we have some change to our cleaning method and the CV is to validate the change.
Some people from our company point out that the minor cleaning in between two major can be seen as a worse case study. Some enven say that due to the manufacturing schedule, we might also insert another product in between, but once the study product is manufacutring the CV can be continue after the major cleaning. I know it sounds stupid to do so, but if the manufacturing line is limit and sell demand is requested, it might happen.
I am wondering if anyone can give me more opinion or even some article I can refere to.