Process Validation runs
Contribution from Dr G. Becker written on 3/22/2002 at 08:30
Is a matrix approach acceptable to reduce the amount of process validation runs. E.g. if there is a tabletting process which differs only in the strength (1 mg, 5 mg, 10 mg). Are three runs with 1 mg and three runs with 10 mg enough or do I need also three runs for the 5 mg?
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