ICH Q12 Implementation: Post-Approval Change Management Protocols

A practical overview of how pharmaceutical manufacturers are implementing ICH Q12 lifecycle management principles into their post-approval change management workflows.

ICH Q12 establishes a framework for technical and regulatory considerations for pharmaceutical product lifecycle management, now being implemented across the US, EU, Japan, and increasingly emerging markets.

The guideline introduces Established Conditions (ECs) and Post-Approval Change Management Protocols (PACMPs), enabling companies to agree upfront with regulators on how to manage future changes.

Implementation Challenges

Organizations report challenges in legacy product retrospective analysis, particularly in defining appropriate ECs for products approved before Q12 existed.

ICH Q12 Implementation: Post-Approval Change Management Protocols

Implementation Challenges

Plus d'articles