FDA has officially endorsed the ICH Q12 guideline for post-approval change management
The guideline ICH Q12 “Technical and regulatory considerations for pharmaceutical product lifecycle management”, provide a globally agreed framework to facilitate the management of post-approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.
This guideline establishes a harmonized approach to defining which elements in an application are considered necessary to ensure product quality (Established Conditions for Manufacturing and Control” – ECs) and therefore would require regulatory submission if changed after approval.
ICH Q12 Core Guideline
defines the concepts of:
- Post-Approval CMC (chemistry, manufacturing, and controls) changes,
- Established Conditions(ECs),
- Post-Approval Change Management Protocols(PACMPs),
- Product Lifecycle Management (PLCM)
ICH Q12 Annexes
FDA also published the Annexes to ICH Q12 which contains illustrative examples describing how to use the principles in the guidance as a framework for managing postapproval changes.