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…
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yes for every chang in batch size validation is req.
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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
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During granulation Take different samples for analysis to ensure assay of product,LoD
At compression stage for content uniformity etc
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