PQ of Performance Qualification RAPID MASS GRANULATOR

Dear Sir,
We have performed IQ and OQ for RAPID MASS GRANULATOR. now i want to ask that how much BATCHES (Commercial or Mock Batch) are to be used for PQ and what are the check points.

Thanks and Regards

Vinay Mangal

Frankly, nobody can answer this question for you. The number has to be statistically justified and only you can do that.

That said, the de facto standard is 3 batches; however, again, you need to still have rationale to support this decision.

Thank you Sir,

Is there any guideline regarding Qualification i.e. IQ, OQ, and PQ.


Vinay Mangal