Ask the Expert: Post-Approval Changes

Pharmaceutical manufacturing processes naturally evolve as companies increase production, optimize processes, and adopt new technologies. In this Ask the Expert discussion, Susan J. Schniepp of RCA and Siegfried Schmitt of Parexel explore how companies can develop a proactive strategy for managing chemistry, manufacturing, and controls (CMC) post-approval changes. Their discussion emphasizes the value of anticipating potential changes during the initial regulatory filing process to improve flexibility, reduce regulatory delays, and support continued manufacturing operations.

The experts review several regulatory pathways available in the United States, including prior approval supplements (PAS), changes being effected in 30 days (CBE-30), and annual reportable changes. They explain that companies can build flexibility into their original submissions by identifying potential alternative manufacturing methods or processes in advance. Comparability protocols are another useful tool, particularly when managing scale-up changes, because they establish a structured approach for demonstrating that changes do not adversely affect product quality.

The discussion also highlights the importance of considering regulatory strategy before approval. Although companies are often focused on getting products to market, planning for anticipated changes early can help avoid the time and expense associated with post-approval submissions, including certain costly variations in Europe. Ultimately, there is no one-size-fits-all approach. Companies should develop change management strategies that reflect their risk tolerance, available resources, and manufacturing needs while ensuring continued product quality and regulatory compliance.

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Link to the Video and Article on Pharmaceutical Technology