March 23, 2022

API PROCESS VALIDATIONS: A Broadway Analogy by Jim Mencel, PhD

Before the stage is set and the curtain rises for a debut performance, the time-consuming process of putting together a Broadway show is the perfect analogy used by Jim Mencel, Senior Drug Substance Consultant at Design Space InPharmatics, to describe process validation for Active Pharmaceutical Ingredients (APIs) when preparing for filing with the FDA.