Process validation

(Varun) #1

Do we need to validate our process if we increase batch size +/-10% in API production

(Madeeha batool) #2

Any change should be first approved through change control procedure by the QA department.
After that validation is performed after any changeā€¦

(Varun) #3

Sorry more than +/- 10%

(Sajjad Ahmad) #4

yes any change in batch size leads to validation.