One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes.
Today’s pharmaceutical manufacturers need to focus attention on their overall quality and compliance efforts in response to the large number of U.S. Food and Drug Administration (FDA) 483 observations and warning letters citing CAPA deficiencies. But having an effective CAPA management system is more than just an important regulatory requirement. It’s good business practice that brings many benefits, such as reduced liability, improved customer satisfaction, prevention of major financial losses, and strengthened company reputation. However, it’s not always easy to do. Most firms have pieced together quality management systems using several disconnected programs, overlapping databases, and even manual pen-and-paper processes. CAPA oversight is typically not prioritized across the entire enterprise and built into standard operating procedures (SOP). The end result of these piecemeal systems is inefficiency, loss of productivity, and repeated citations for the same nonconformance.
A search for “corrective and preventive actions” in warning letters on the FDA’s website returned almost 800 results of both medical device and pharmaceutical companies. In one such warning letter to a pharmaceutical company, the FDA states: “Your firm failed to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR § 820.100(a). Specifically, your firm has not established procedures to analyze and document quality data to identify and investigate existing or potential causes of nonconforming products or other quality problems, as well as procedures to verify, validate and implement corrective and preventive actions and ensure that relevant information is submitted for management review. Furthermore, your firm failed to document any CAPA activities and their results.”
While the FDA’s focus is on non-conformity investigations and corrective action, preventive action is central to the new continuous improvement/quality system paradigm. Expect to see significant compliance expectations for the pharmaceutical industry.
It is important to remember that CAPA compliance is a large process involving many aspects of an organization. True CAPA conformity, being able to quickly identify and correct problems while putting practices in place to prevent future issues, requires the integration and flow of information freely across a company’s various departments and locations. It’s an investment worth making, as it will give pharmaceutical companies the ability to quickly identify and address deficiencies and prevent them. It can drive a company’s continual improvement efforts and help them achieve operational excellence both in product and process, translating into increased performance and greater revenue.