Annex II: Potential Applications

ICH Q9 QUALITY RISK MANAGEMENT

II. 7 Quality risk management as part of…

Industry

Laboratory control Competent

Authorities

and
stability testing

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT

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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2