Batch Manufacturing

In a BMR there is provision to reduce the pH of batch , but during PV batches pH adjustment(reduce) not required as pH found within limit , but during commercial arch manufacturing in one batch pH observed higher from the Limit, and HCl is used to reduce the pH( out of trend) . In this scenario any additional sampling required, if yes what testing to be done with additional sample.

In this case, a deviation should be filled with proper justification.

can i get help with a BPR-Batch production record format