II. 7 Quality risk management as part of

1
II. 7 Quality risk management as part of
Industry
Competent Authorities

• Laboratory control and stability testing

2
II.7 QRM as part of laboratory control and
stability testing

• Out of specification results
• To identify potential root causes and corrective
  actions during the investigation
• Retest / expiration date setting
• To evaluate adequacy of storage and testing of
  intermediates, excipients and starting materials
• Challenge results of use tests
• Stress tests

ICH Q9