if batch size is changed from 200 kg to 180 kg then what is the criteria
AsifHussain (Md.Asif Hussain) #2
Revalidation due to change in batch siZe.
arvind1620 (Arvind) #3
Also need to establish the impurity profile
Sajjad_Ahmad (Sajjad Ahmad) #4
raise change control
mention justification of change
revalidate 3 batches.