Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
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SOPs‣ SOPs are not executed consistently for themanagement <strong>of</strong> deviations, change control,laboratory records, and logbooks.‣ Standard operating procedures are not alwaysfollowed by operators. Specifically, several criticalnon-conformances resulted from disregard <strong>of</strong>standard operating procedures by both operatorsand second verifiers <strong>of</strong> critical operations.‣ Numerous deviations due to SOPs been withdrawn& newer version not available at different areas <strong>of</strong>the facility.33
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