I want know that we can performance Qualification with Process validation if yes then please explain my doubt are as follow
1- If PQ and PV done with same batch then sampling is done seperately for PQ and PV or Consider Only PV sampling and result of PV sampling attached with PQ report kindly explain
2- If we done PQ with dumy batch how can we perform it e.g if we want to PQ of RMG how can we perform it with alone dumy batch and or with PV Batch
3- what will be the parameters to qualify the RMG with dumy batch please explain
Hello, Prakash, and welcome!
PPQ (formerly PV) cannot be done until all equipment, systems and facilities have been previously qualified. PQ should be performed to challenge worst case conditions that encompass all products considered in the mfg line, while PPQ is performed for each product at routine/nominal conditions in order to verify that the whole process variation is capable to meet product specs (using qualified facilities, utilities, equipment, control strategy, cleaning, etc.).
It is a common practice to use a placebo to test the RMG during PQ runs at conditiones considered worst case, to cover all products, and test for process outputs like particle diameter distribution or humidity. Specific product or process CQAs may not be possible to test at PQ stage, since the rheological properties of the powder and granules depend heavily on the interaction with API and components of the mixture, these should be tested during PPQ runs.
I hope this is useful.
Thanks