Good day. I understand that Process Validation (PV) needed to be done for 3 consecutive batch for every new products and existing product that undergone changes.
Just curious to ask, if example that registration batch size is 300kg, and PV is done. And intended to do another batch size of lesser or higher than 300kg, with all the equipments used same, can i skip the PV again for the new batch size? And whats the batch size range if i were to need to exclude for PV ? Any guide that can help? As all guide is telling that all batch size needed to do PV if it is different with reg batch size. Thanks
2 Likes
Every batch size should be validated either it is increased or decreased.
The b.size changing means, there is change in quantities of input raw materials including with KSM, according to the b.size.
There is no specific range for the b.size variation acceptance, every change that has to be impact on the quality/yield /strength/efficacy…considered for validation