How much times a batch size can be increased after validation? Is validation is required for every time batch size change?
For every change in batch size either increase/decrease, validation to be carried out…
yes for every chang in batch size validation is req.
But i get to know from one of my senior that we can increase batch size up to 10 time as per ICH after any validation.
Sir ye validation ka process b btaiye ksa krna hoga
During granulation Take different samples for analysis to ensure assay of product,LoD
At compression stage for content uniformity etc