Manufacturing Tracking and Control Systems – State of the Art Practice for Parametric Release Sterilization Programs

Explore how to improve risk mitigation and enhance manufacturing compliance that, as a result, can be leveraged as a tool for the development of an effective parametric release program in sterile parenteral manufacturing. The presentation describes the concept, development and successful implementation of a Manufacturing Tracking and Control System (MTCS) installed at several large volume parenteral manufacturing facilities and its impact on the manufacturing operations which employ parametric release programs at those facilities. Attendees will benefit from an overview of a potentially superior alternative to the existing sterilization program tools that also increases manufacturing regulatory compliance, eliminates operational errors, expedites product disposition and guarantees product segregation.