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Compliance In Focus
Posted by John Lehmann on Fri, Jun 1, 2012

The Importance of CAPA

I love the straightforward definition this website provides on CAPA. “Simply put, Corrective Action isFDA CAPA based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions are integral parts of a continuous improvement program.”

Sometimes it seems like a negative stigma surrounds CAPA- it’s not such a bad thing! In truth a well written, implemented CAPA can make all the difference in terms of compliance. Yes, there was an issue needing correction, but an effective CAPA will prevent the noncompliance from reoccurring and nip the issue in the bud.

An effective CAPA system can help prevent a warning letter during an audit. A recent blog we posted talks more in detail about FDA Audit Responses and Corrective Action Plans from this angle. During an FDA inspection, the agent will look closely at the CAPA system at an investigational site. This ensures compliance, and a good CAPA system will help protect patients and data integrity. In fact, on the FDA website, a flow chart and questions are available to help understand CAPA inspectional objectives.

An MD+DI article also covers the importance of CAPA. The article mentions that it’s important when documenting a CAPA to:

  • Create a structure for directing current and future activities
  • It can be used as tool for forward and backward traceability
  • Explain how compliance with the requirements was obtained to correct nonconformity and employed reasonable measures to limit the risk.

What are your thoughts on CAPA systems? Do you have any suggestions for what works and what doesn’t? Share your experiences with us!

Photo Credit: keaggy

Topics: CAPA, Corrective and Preventive Actions, FDA


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