PDA Letter Article

Prospects for Post-Approval Change Management

by Naheed Sayeed-Desta, Apotex, Ajay Babu Pazhayattil, and Ivy Louis, Vienni Training and Consulting LLP

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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).