Guideline on Process Validation

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Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. It is recognised that, at the time of submission, ... For solid oral dosage forms this size should generally be 10% of the maximum production scale or 100,000 units whichever is the greater. 1. Where

  Process, Validation, Unit, Process validation, Adequacy, Dosage, Demonstrates, To demonstrate