Setting up a System of Success

How a team of on-site validation experts offset the challenges of getting a new biopharmaceutical manufacturing facility up and running

Managing a new facility start-up can seem like a constant race against the clock.

In 2016, with limited in-house resources to dedicate to the validation of a new facility, a top-20 U.S. biopharmaceuticals manufacturer faced the challenge of building a new active pharmaceutical ingredient manufacturing facility from the ground up.

Learn how engaging Azzur Group for full-scale GMP-compliance project management and execution allowed the client to meet their goal.

The Rundown

The Challenge

Facility start-up for new API manufacturing facility

The Team

Azzur New England

The Solution

  • Design qualification 
  • Facility validation master plan 
  • Verification/qualification for installation, operation, and performance

The Impact

On-site, autonomous engineering consultants who efficiently supported validation activities for the new manufacturing facility, ensuring the client was set up for success by mitigating impact to client staff and their day-to-day roles
In your opinion, how well-equipped is your internal team to handle validation for a new facility start up?
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