|Clinical research pros can learn from manufacturing
when it comes to leveraging CAPA.
Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and shouldleverage CAPA principles in clinical research.
“If you work in clinical research, you can use CAPA strategies that have been tried and tested in manufacturing and adopt them for your specific needs. The CAPA framework for investigating a quality issue is applicable in clinical as much as another area,” said Santos-Serrao, MasterControl’s director of clinical and regulatory solutions for the pharmaceutical, blood, and biologics industries. She shared five CAPA best practices that you can adopt in clinical trials in an article she wrote for Pharmaceutical Commerce.
CAPA & Manufacturing
In pharmaceutical and biopharmaceutical manufacturing, you can assume that somewhere along the line, something is likely to go wrong that could affect quality. When that happens, the quality issue must be resolved in a timely, effective, and compliant manner.
“If the problem is minor and there’s a solution that can be performed immediately and sufficiently, then the quality event can be closed with an effective containment or correction,” Santos-Serrao said. “If the issue is significant, it will be escalated into a CAPA.”
She said clinical research professionals have been using CAPA more than most people realize. But, unlike in manufacturing, there’s less emphasis in formalizing CAPA procedures and embedding them in a clinical trial’s quality process, or in integrating them with the QMS. Indeed Santos-Serrao coined the term “clinical quality management system” or CQMS for MasterControl only five years ago.
There is much to be learned from the manufacturing sector when it comes to leveraging CAPA. Santos-Serrao said these CAPA best practices can strengthen clinical research not only for compliance purposes but to help accelerate time to market.
#1 Establish a CQMS and make CAPA a part of it.
If you are in the process of creating a clinical quality management system, integrate a CAPA process from the get-go for a smoother clinical trial. Take advantage of the latest technology and adopt an electronic CQMS for managing CAPA and also your trial master file.
#2 Integrate training control with CAPA to boost compliance.
Clinical trial sites must follow the study protocol and corresponding SOPs to exact specification. One way to make sure that this happens is by training investigators and support staff on the protocol and SOPs and to conduct ongoing training with regard protocol amendments.
#3 Integrate CAPA with risk management for a holistic approach to quality.
If your company has a risk management process but not a CAPA process or vice versa, you are not optimizing each process. Use them to complement each other.
#4 Identify which deviations warrant a CAPA and match the corrective action to the severity of the problem.
Not every quality issue requires a corrective action and not every corrective action calls for a preventative action. The decision on what type of action is needed should be based on a number of factors, such as risk, impact, severity, and frequency of the event.
#5 Make your CAPA process transparent to increase your audit and inspection readiness.
All essential documents are subject to audits and inspections. In a manual process, paper documents are hard to track and can be easily misplaced. There’s nothing worse than failing to produce an important document during an audit. When you automate your CQMS, you will have a single centralized repository for all CAPA documents and other important records. Auditors will need to look at only one place for anything they need.
Read Patricia Santos-Serrao’s article on Pharmaceutical Commerce:
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.