Following successful completion of the process qualification, the process can be used for commercial supply of the API. The process to ensure product quality does not end with product launch.

In this interview, NewsMed talks to Dr. James Mencel's Guidance about Scaling Up API Processes. Could you introduce yourself and your experience in the pharmaceutical industry? I obtained a B.S. in ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

To him, API governance elevates the business by delivering a more “confident impact assessment of making process enhancements or modifications.” It also provides a common forum for the company to ...