Does Your CAPA Process Need a CAPA?
Corrective & Preventive Action - 27 April 2016
I have had the opportunity and privilege to work in the pharmaceutical industry for the entirety of my professional career, which spans several decades. I came into the industry while ‘Testing Quality in’ was the norm. I have seen and worked through the development of the CGMPs, and the introduction of a radical new concept at the time, called ‘validation’. What was once the cutting edge is now the prevalent, dominant reality, and new ‘cutting edges’ emerge all the time, with startling regularity.
With the global expansion of the pharmaceutical industry, the application of risk management to the supply chain became vitally and unavoidably important. The biggest change I have seen recently is the importance that regulators and industry now place on the design and performance of quality systems. It is not overstating the case to say it is currently essential that companies have Enterprise Quality Management Systems (EQMS).
One of the keystone processes in any Quality System is the Corrective Action and Preventive Action (CAPA) process. It is almost always evaluated for efficacy by regulatory investigators. It is key to preventing internal and external failures, and without it continuous improvement cannot be accomplished.
"One of the keystone processes in any Quality System is the Corrective Action and Preventive Action (CAPA) process. It is almost always evaluated for efficacy by regulatory investigators. It is key to preventing internal and external failures..."
Does your CAPA system meet current expectations and reflect best practice?
Let’s examine some of the common problems with CAPA processes:
- . Target dates for the completion of CAPAs are frequently missed
- . Target dates for the completion of CAPAs are frequently extended
- . Performance metrics lacking or non-existent
- . CAPAs are not categorized properly, usefully or at all
- . Little or no trending exists, or has been set in place
- . Effectiveness checks are not routinely performed, or are not appropriate
- . Too many corrective actions and not enough preventive actions mean that we hyper-correct, yet potentially leave ourselves exposed in the future
With a well-designed EQMS in place, you can improve both product quality and your quality system incrementally–and avoid some of the regulatory inspectional observations and shortcomings outlined above, which we see more often than not.
About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and APIs with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.