White Paper

The Role Of Operational Readiness & Capital Projects In Drug Manufacturing

Source: CAI

By Josh Hoops, Global Director, Program & Project Management

Cell and Gene pharma manufacturing bioprocess GettyImages-1166528646

In the Pharmaceutical Industry, managing the various stages of a Capital Project is not for the faint of heart. Whether the project is to replace all of the light bulbs in the facility from incandescent to LED, or building a new 250,000 sqft Manufacturing Facility, navigating the complex web of planning and execution requires an understanding of a multitude of aspects in the lifecycle of project delivery.

As a Project Manager, one approach that can greatly aid in wrangling a “hair on fire” team in to a cohesive and collaborative unit, is to focus on achieving Operational Readiness once the project is complete. One definition of Operational Readiness is “the state of preparedness attained by an organization when they can safely and efficiently startup, achieve design throughput with the design timeframe, and operate that process in control, in a sustainable and environmentally friendly manner”.

Breaking down that definition and translating it to actual Project Management practices is not as daunting as it may seem. When the team is in the initial throws of the Initiation and Planning processes, if the focus on the desired outcome is Operational Readiness, and not solely on the delivery of the facility, equipment, and supporting systems, many aspects of the project that typically lie on the periphery will come to light.

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