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No. of PV Batch for Machine Changed

#1 · September 18, 2024, 5:02 am

How many PV batch(es) should be taken for equipment/machine (e.g., compression machine) changed?

Is there any specific guidance?

#2 · September 19, 2024, 6:13 am

Neither the cGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process. FDA's process validation guidance now recommends a product lifecycle approach.

But for change of equipment that involves different design and operating parameters/principles you should go for re-validation.

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