Annex II: Potential Applications

ICH Q9 QUALITY RISK MANAGEMENT

II. 7 Quality risk management as part of«
Industry

Laboratory control and stability testing
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance

Competent Authorities

July 2006, slide 1

7: QRM as part of laboratory control and stability testing y Out of specification results > To identify potential root causes and corrective actions during the investigation y Retest / expiration date setting > To evaluate adequacy of storage and testing of intermediates. not an official policy/guidance July 2006. excipients and starting materials  Challenge results of use tests  Stress tests ICH Q9 prepared by some members of the ICH Q9 EWG for example only. slide 2 .Annex II: Potential Applications ICH Q9 QUALITY RISK MANAGEMENT II.

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