Facility startups rely on a rigorous commissioning and qualification process to succeed today, and in the future. Here’s what commissioning services involve and how they benefit biopharma facilities.
Commissioning and qualification (C&Q) is the process by which facilities, systems, and equipment are both established, confirmed, and verified to be suitable for their intended use.
The commissioning side involves the work that engineers and construction professionals complete while building or renovating a biopharma manufacturing facility.
Commissioning professionals not only review engineering designs, but they develop risk assessment and management procedures, as well as commission and decommission utilities. Commissioning also involves collecting installation data, testing a system’s functionality, and then fixing any issues that were found.
Qualification includes demonstrating that utilities and equipment will function as needed. According to the ISPE, there are three specific types of qualifications carried out in biopharma manufacturing facilities. All three are considered to be “verification” activities.
As complex as commissioning and qualification might be, the process serves an important role in the biopharma field.
For one, biopharma is a highly regulated industry, so proper commissioning and qualification help ensure compliance with FDA CFR 21 Part 211. This measure dictates proper, safe manufacturing procedures and documentation for facilities producing pharmaceuticals.
Additionally, thorough commissioning and qualification allow for a streamlined regulatory inspection process in the future. While C&Q has the potential to be extensive, both processes are all about laying a good foundation for a facility’s future operations.
Equipment that has not been appropriately tested and documented cannot be safely used. Your facility also won’t have an accurate idea of what the equipment is capable of. By testing a piece of equipment according to its original manufacturer’s guidelines, you’ll be able to assess if the equipment is meeting average industry standards. Performance testing allows you to verify that the machinery can meet your facility’s needs, and provide the opportunity to make changes or add equipment as needed.
Most importantly, by starting with a clear idea of what a machine is capable of, your facility can minimize downtime and start production sooner.
Risk assessment and management are a key part of the CQV process. By evaluating a facility’s designs and manufacturing intentions, bioengineers can help evaluate potential risks your facility could face. Then, they can help determine the safest, best practice strategies for mitigating risk and resolving potential issues.
With CQV, you can rest assured that your facility’s design and equipment are going to produce the results you need. Commissioning and qualification isn’t just about maximizing productivity or eliminating risk — it’s also about ensuring your facility has the foundation it needs to manufacture the highest quality products.
Don’t neglect a thorough CQV process. With Bothwell Engineering, you’ll be equipped with the team of experts you need to help your facility meet the latest industry standards. From development to commissioning, we can help your facility startup successfully navigate the complexities of the CQV process.
Contact us today for an initial consultation.