Full Scale Operations For Parenteral Pharmaceuticals

In a collaborative venture with a leading parenteral pharmaceuticals manufacturer, CAI embraced the challenge of elevating manufacturing standards through an Operational Project Management (OPM) services approach. The project's focal point was the evaluation, upgrade, and requalification of critical components, including autoclaves, vial washers, depyrogenation tunnels, data recorders, vial and syringe fillers, dry heat ovens, and cappers. CAI led an integrated US and European project team was led through accelerated milestones in the development, approval, and execution of equipment evaluations, equipment specification documents, installation qualification, and operational qualifications. Further, CAI helped drive the culture shifts necessary for the validation and qualification of equipment and processes. Explore the multifaceted approach CAI employed, highlighting the pivotal roles of people, processes, and the facility in achieving a streamlined, efficient, and compliant pharmaceutical manufacturing environment.