May 30, 2013 12:12 pm EDT
The following key elements from ICH Q10 provide strong rationale for conducting both internal and external audits:
Include both internal and external audit results as part of the process performance and product quality monitoring system
Implement corrective actions and preventive actions (CAPA) as a result of audit observations
Include audit results as part of management review of the quality system
Consider feedback from periodic internal audits and external audits in con
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