What are various parameter limits for HVAC validation. If we have to treat a change in formulation do we have to take 3 compulsory commercial batch trials and then proceed for a permanent change in the 4th batch or we shall take 3 R&D trials and

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What are various parameter limits for HVAC validation. If we have to treat a change in formulation do we have to take 3 compulsory commercial batch trials and then proceed for a permanent change in the 4th batch or we shall take 3 R&D trials and its study is enough?

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