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Corrective Action & Preventive Action (CAPA) Effectiveness Checks

Corrective & Preventive Action - 12 August 2015

The need for periodic performance and effectiveness checks should be agreed upon and documented as part of a compliant Corrective Action & Preventive Action (CAPA) process. This is a practice that inspectors and auditors look for when evaluating a firm’s Quality Management System (QMS). CAPA are among the most common Quality processes, and—when properly handled—can save you from serious repercussions!

Risk management principles should be applied during selection and design of the effectiveness checks. Your CAPA SOP should discuss this risk-based approach, as well as clearly indicate that effectiveness checks may not necessarily be required for all CAPA processes.

One way to do this is to assign a product impact category to each CAPA (e.g. high, medium or low). In this way, the need for an effectiveness check can be defined for each category in the SOP, and at the same time you will avoid any criticism regarding the lack of consistency.

Additionally, the ranking can help with the prioritization of CAPA, and help support longer target completion dates, e.g low impact CAPA. Using this methodology and, if required, a scheduling chart, companies can budget resources and expertise across time, using the prioritized impact categories as a guide.

When effectiveness checks are required, make sure that the effectiveness check(s) can properly evaluate or measure the effect of the action(s) taken. Metrics and tracking are your friends in this context, as good results that demonstrate savings and operational ease will enable others down the road to benefit. Effectiveness checks should always be a value-added activity, performed in earnest and not just be ’window dressing‘, or simply for show.


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.

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