Process Validation

August 19, 2021

Trust and Expertise: Defining The Value Of The Person-In-Plant

As sponsors have started to shift more and more of their manufacturing to outsourcing partners, relationship building has become an even greater priority. This is where the person-in-plant becomes an invaluable source for building a more trusting relationship with the contract research manufacturer (CMO). Essentially, a person-in-plant is a sponsor employee or, more often, a third-party expert consultant who is present at the contract manufacturing site to observe, support, and provide feedback to all stakeholders.
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.