Please suggest me,
In 1st three validation batches CPP’s are found out of limit then it is accepted by regulations??
e.g. amperage reading limit is 25-35 and it find 37 then is it ok or not although there is remark has been provided in BMR and PVP for parameters are tentative and shall be finalised after validation batches.
Before taking up of process validation, trail batches can be considered upto getting the confidence on the manufacturing process like CPP.
Once BMR has been approved, the same has to be used for process validation and commercial batches.
Means in pv batches it is not acceptable?
Yes. In that case deviation needs to be raised and validation will be canceled accordingly.