Lessons From Experts in A Two-Part Series on CAPA Verification of Effectiveness

A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process.

Between drugs and medical devices, however, FDA’s regulations differ significantly — although the intent is consistent — as the regulations governing CAPA requirements for medical devices are far more explicit than for drugs.

Regulation and guidance describe CAPA requirements as an essential component of cGMP for both drugs and medical devices. However, some companies may fall one step short of a closed-loop CAPA system. That is, some companies may not perform an appropriate verification of effectiveness (VoE) to objectively determine whether actions were effective in eliminating the root cause of the problem.

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