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A range for a critical parameter that has been determined to be achievable and appropriate for the process or processes with which it is associated. It is established by knowledge gained through relevant documentation and actual testing. A process should perform consistently and as intended when all critical parameters are held within the established PARs.
Publication Source: ISPE Baseline® Guide, Vol. 2: Oral Solid Dosage Forms (First Edition)
Publication Date: 1998
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