What is CQV?
Commissioning, verification, and qualification (CQV) is the process by which facilities, utilities, and equipment are installed, functionally tested, and verified to be suitable for their intended use.
Commissioning
Commissioning involves the work that engineers and construction professionals complete while building or renovating life science manufacturing facilities.
Commissioning professionals review engineering designs, author test documentation to comply with good engineering practices (GEP) and the latest industry standards, verify the correct installation and shake down equipment to minimize issues encountered during the qualification phase.
Qualification
Qualification demonstrates utilities and equipment function as intended. According to the International Society of Pharmaceutical Engineers, there are three specific types of qualifications conducted in Life Science manufacturing facilities.
· Installation Qualification (IQ): Documented process verifying facilities, systems, utilities and equipment, comply with design and manufacturers recommendations and are fit for the intended purpose.
- Operational Qualification (OQ): Documented process verifying facilities, systems, utilities, and equipment, as installed, or modified, perform as intended throughout the anticipated operating ranges.
· Performance Qualification (PQ): Documented process verifying facilities, systems, utilities, and equipment, when operating together, can perform effectively and reproducibly, based on the approved process method and product specification.
Why Does Commissioning and Qualification Matter?
As complex as commissioning and qualification might be, the process serves a vital role in the life science field.
Compliance and Regulation
For one, the production of pharmaceutical drug products is a highly regulated industry. Robust commissioning and qualification help ensure compliance with FDA CFR 21 Part 211.
FDA CFR 21 Part 211 dictates proper, safe manufacturing procedures and documentation for facilities producing pharmaceuticals.
Additionally, thorough commissioning and qualification allow for a streamlined regulatory inspection in the future. While commissioning and qualification is time consuming and expensive, both processes are all about laying a good foundation the transition to commercial manufacturing.
Increased Efficiency
Equipment that has not been appropriately tested and documented should not be used in the manufacture of drug products. Doing so is a safety risk, and could result in adverse regulatory action, as well as resulting in manufacturing down time. Investing the time and money in a stringent commissioning and qualification effort up front will ensure facilities, systems and equipment are fit for purpose and operate as intended when a facility goes live.
Most importantly, by starting with a clear idea of the safe and efficient operation of the facility, utilities, and equipment, it reduces the risk of rework to comply with industry regulations, minimize downtime, and ensure your manufacturing facility is ready for production on day one.
Minimizes Risk
Risk assessment and management are a key part of the CQV process. By evaluating a facility’s designs and manufacturing, CQV engineers can help evaluate potential risks your facility could face. Then, they can help determine the safest, best practice and strategies for mitigating risk and resolving potential issues.
Ensures Improved Quality of Results
With a well-executed commissioning plan, you can rest assured your facility’s design and equipment are going to produce the results you need. Commissioning and qualification are not just about maximizing productivity or eliminating risk — it is also about ensuring your facility has the foundation it needs to manufacture the highest quality products.
Benefits of Outsourcing Commissioning, Qualification, and Validation Services to Bothwell Engineers
Do not neglect a thorough CQV process. With Bothwell Engineering, you will be equipped with the team of experts you need to helpensure your facility meets the latest industry standards. From developing a commissioning plan to executing the associated activities, Bothwell Engineering can help your facility startup successfully navigate the complexities of the CQV process.
Contact us today to share how we can support your organization with CQV and resources to accelerate your organizational goals.
