Designing Flexibility into CGT Facilities: The CQV Advantages

Knowing that you’re prepared to face unexpected hurdles and delays during your facility design is a huge advantage. And by leveraging current trends, like modular pods and equipment, you can meet changing business needs in an agile way.
When shifting to a flexible facility design, engaging with a commissioning, qualification, and validation expert as early as possible is crucial so you can head off any roadblocks.
Why? Because having a reliable and consistent CQV partner from the get-go gives you a safety net throughout your construction process, reducing rework and ensuring your flexible facility is sticking to its timeline with limited interference.

Related: A CQV Checklist for Gene Therapy Facilities

Benefits of Designing Flexible Facilities

Pharma Manufacturing shares that a “flexible facility is one that is agile enough to adapt to change — whether it be a shift in capacity needs, regulatory demands, manufacturing processes, technologies, products, or some combination thereof.”

Modular designs allow manufacturers to improve product quality, easily replicate processes, and maintain flexibility with the available infrastructure while minimizing manufacturing delays. This means that manufacturers are in a key position to showcase their ability to adapt to the growing cell and gene therapy market and deliver quality products more quickly by adopting these flexible facility designs.

Related: Flexible Manufacturing: Mods and Pods in BioPharm

The CQV Advantages of Flexible Facilities

While modular systems typically come factory acceptance tested to verify the equipment works as intended prior to installation at your facility, thorough on-site site acceptance testing, validation and documentation is needed to ensure the equipment is ready for production.
Incorporating a CQV process from the beginning gives you the foresight to reduce delays and spot gaps ahead of time, keeping you on your timeline. The benefits of working with an experienced CQV firm include:

A Trusted Partner

Having a trusted CQV partner come in at the start of design gives you a leg up on the competition. It allows you to anticipate potential risks and mitigate as appropriate. A reliable partner can also give you insight into the ever-changing regulatory processes.

Attention to Quality

There is no doubt that getting a quality product right the first time is of utmost importance for you, the client, and above all else, the patients in need. Running into quality control issues can happen without the proper internal controls. Your flexible facility design process is as much about building in quality control processes as it is about the actual brick and mortar design.

Speed to Market

When you’re on a deadline, the pressure to get a product to market is palpable. One of the most frustrating things that can happen when you’re on a deadline is having to go back and redo work. Not only is it costly, but it can also damage employee morale and generate some bad press for your company.

How Will You Incorporate CQV into Your Future Facility’s Design?

Don’t let a commissioning, qualification, or validation issue disrupt your flexible facility’s progress. ICQ is here to serve as your partner in the CQV process throughout the lifecycle of your facility — from design to start-up and beyond.