Chapter 1

The Challenge



In 2016, a top-20 U.S. biopharmaceuticals manufacturer faced the challenge of building a new active pharmaceutical ingredient (API) manufacturing facility from the ground up. With limited in-house resources to dedicate to the validation of the new facility, the client sought an outside team to lead and execute the qualification — in the middle of a full QMS integration effort. Azzur Group was the solution — providing full-scale GMP-compliant project managers and engineers who collaborated with the client's validation team at every step of the process.
 
Azzur's engineering experts are committed to helping clients start up or renovate their facility, utilities, systems, and equipment (FUSE) through our commissioning and qualification (C&Q) services. We strive to provide cost-effective solutions in a timely manner. Our streamlined engineering practices use a risk-based approach.
 
At Azzur, our goal is to understand the unique requirements of your process and product and to build a plan focused on the associated critical aspects while maintaining regulatory compliance. Our SMEs are backed by real-world experience and the technical skills to help make your project a success.
In your opinion, how well-equipped is your internal team to handle validation for a new facility start up? :
Not readyVery Well-Equipped