Do we need to validate our process if we increase batch size +/-10% in API production
Varungulya (Varun) #1
Madeeha (Madeeha batool) #2
Any change should be first approved through change control procedure by the QA department.
After that validation is performed after any change…
Varungulya (Varun) #3
Sorry more than +/- 10%
Sajjad_Ahmad (Sajjad Ahmad) #4
yes any change in batch size leads to validation.