How many batches are required for Machine PQ?

After completion of IQ/OQ for any equipment, is there need three batches for the performing of PQ or one batch is sufficient?

3 batches

Thank You. Can I use three commercial batches for the market or need three placebo batches?

U can use commercial batches and compare the output product quality parameters with previous approved batches…If no abnormalities are identified w.r.to quality, u can dispatch the product and considered as the equipment is qualified…

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Thank You So Much Bro. If possible pls send me a PQ Protocol for any Equipment.


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