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• Prioritized
audits give first and most in-depth attention to areas that present
the highest risk to product quality, for example:
– Aseptic processing; terminal sterilization; formulation;
labeling; others that directly impact safety, purity, potency,
efficacy
Audit Process
• Generate annual audit schedule
• Inform system owners of planned audit dates
• Assign workload to auditors
• Generate audit plans, share with system owners, adjust as
necessary
• Conduct audit; provide immediate feedback on findings;
collaborate to resolve any dispute or disagreement
• Prepare draft report, share with auditee
Cont..
C.6.1.1 Complaints
C.6.1.1.1 Is there a written procedure for product
complaints?
C.6.1.1.2 Who is responsible for:
a) Logging;
b) Classifying;
c) Investigating complaints
• Chapter 7
C.7 SELF INSPECTION
C.7.1 Short description of the self-inspection system