An Introduction To Operational Readiness In Drug Manufacturing

By Richard Tree

Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to start up as soon as possible once the project is completed but also to achieve steady state throughput as quickly as possible after the startup begins. This type of startup is what is called a “Vertical Startup.”

The first step requires management teams to transition their focus from a process qualification milestone to an Operational Readiness milestone. Once this happens, operations departments can achieve a Vertical Startup by applying the principles of Operational Readiness, a proven methodology used across the spectrum of manufacturing industries. Often, Operational Readiness is not fully understood, not correctly applied, or confused with the principles of Operational Excellence.

Learn about Vertical Startups and why Operational Readiness is the organizational state that must be reached for vertical startups to exist. Further, build an understanding of Operational Excellence in addition to Operational Readiness.