Great insights into Advanced Process Controls expanding in the Biopharma industry by Saly Romero-Torres and team.
Key takeaways:
The fundamental controls techniques (FDC, SPC, R2R, etc.) used in Semiconductor manufacturing apply in Pharmaceuticals
FDA regulations make applying active controls difficult, and new guidelines need to be adopted (ICH Q12)
Use of Advanced Process Controls are a critical enabler to faster, cheaper, more reliable drug manufacturing
