Post-Approval Change Management Under ICH Q12

Summary

ICH Q12 promises faster post-approval changes, but few companies use established conditions and PACMPs. This draft explains how to put them into a dossier and run the change process.

Key takeaways

1. 01Defining established conditions in a dossier
2. 02Writing a post-approval change management protocol
3. 03Aligning change control across regions
4. 04Lessons from early adopters

Written for

• CMC programme managers
• QA heads
• Regulatory affairs