Batch size change process

(pariksha) #1

if batch size is changed from 200 kg to 180 kg then what is the criteria

How Cpk values are derived?
(Md.Asif Hussain) #2

Revalidation due to change in batch siZe.


(Arvind) #3

Also need to establish the impurity profile

(Sajjad Ahmad) #4

raise change control
mention justification of change
revalidate 3 batches.