Prospects for Post-Approval Change Management
![syringe and vials syringe and vials](/images/default-source/default-album/pda-letter/new-portal/articles/june-2018/syringe-and-vials.jpg?sfvrsn=414e8b8e_0)
As new types of biologic products enter the market, the need for innovative processes continues to grow. This requires improvements in post-approval change management. ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management offers a solution to post-approval change challenges in the form of a post-approval change management protocol (PACMP) (1).