Process validation

[Varungulya (Varun)]

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

[Madeeha (Madeeha batool)]

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

[Varungulya (Varun)]

Sorry more than +/- 10%

[Sajjad_Ahmad]

yes any change in batch size leads to validation.

[jayaram (Jaya)]

Not only 10%, even u want to change the batch size by +/-1% you should validate the process…