This paper discusses various issues involved with process improvement in pharmaceutical manufacturing firms which creates impediment in introducing change in manufacturing process and refers to the initiatives taken by PAT (Process Analytical Technology) Framework, which encourages pharma companies to introduce change in manufacturing processes for productivity improvement. Setup time contributes a substantial amount of reduction in machine availability in pharma companies. Through a case study of a pharma manufacturing firm the paper explains how SMED can be implemented resulting substantial saving of down time without increasing the work load of the operators. It shows how the activities involved in machine setup can be divided in two classes—internal and external—and how ECRS (Eliminate, Combine, Rearrange and simplify) principles can be applied to reduce the activity time.
Process analytical technology case study, part III: Calibration monitoring and transfer
