FDA ADOPTS ICH Q12

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.

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

ICH Q12: Implementation Considerations for FDA-Regulated Products