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
This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Auditing Investigations & Inspections. Read More!
If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.
This product has been added to your shopping cart. You can
continue shopping or proceed to
checkout.