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The approach whereby manufacturing and quality data generated in validated Manufacturing Operations is screened to present or report only critical process exceptions required by approvers for review and disposition of intermediates and products; requirement for human review/approval of completed Electronic Production records only when a production parameter is out of specifications or there is some other discrepancy or critical exception condition.
Publication Source: GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach
Publication Date: 2010
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