Updated: ICH Q12: A Framework for Managing Post-Approval CMC Changes
The US Food and Drug Administration (FDA) on Wednesday made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management.The 34-page draft aims to help facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceutical drug substances and drug products.
Sections of the draft focus on the categorization of post-approval CMC changes, established conditions, post-approval change management protocols, product lifcycle management, pharmaceutical quality system and change management, the relationship between the regulatory assessment and inspection and post-approval changes for marketed products.
The draft features a decision tree on established conditions for manufacturing and control, noting when notification or prior approval is necessary based on the level of potential risk of a proposed change.
FDA said the draft is intended to demonstrate how increased product and process knowledge can contribute to a reduced number of regulatory submissions, leading to a reduction in unnecessary costs and burdens for manufacturers and regulators.
The guidance also encourages continual improvements on products, FDA said, which may help reduce variability and mitigate some shortages related to manufacturing and quality issues.
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Q12 Annex
Updated on 5/31/18 with a link to the annex.