BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
Batch Production Record, Device History Record Review and Quality Assessment
10 June 2014, Fremont, United States
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Online Event, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United States
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GlobalCompliancePanel
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