Q9 Lab Control and stability studies

1. Annex II: Potential Applications
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
ICH Q9 QUALITY RISK MANAGEMENT
II. 7 Quality risk management as part of…
Laboratory control
and
stability testing
Competent
Authorities
Industry

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