What is CAPA under FDA 21 CFR 820.100?

February 7, 2017 BY by courtesy of greenlight.guru

Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization's processes taken to eliminate causes...

“Corrective Action and Preventative Action” known as CAPA falls under FDA 21 CFR 820.100. Those who are in FDA Regulatory Compliance space or holding Quality Assurance responsibility would appreciate the following.

Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions which are required to be taken and implemented in an organisation at levels of manufacturing, documentation, procedures or systems in order to rectify and eliminate the recurrence of nonperformance. Non-conformance may be a market complaint or customer complaint or a failure of a machinery or a quality management system, or misinterpretation of written instructions to carryout a work. The corrective and preventive action is designed and required to be systematically implemented and observed for its ability to eliminate further recurrence of such non-confirmation in future.

Those who works in FDA (Food and Drug Administration) Regulatory Compliance or Quality Assurance capacity will appreciate the following, that it requires manufacturers of medical devices to have clearly documented procedures for corrective and preventative action in the following seven areas, preliminary:
 
1. Analyzing processes,
2. Investigating the cause of nonconformities ,
3. Identifying the action(s) needed,
4. Verifying or validating the action,
5. Implementing and recording changes,
6. Ensuring that information is appropriately disseminated, and
7. Submitting relevant information for management review.

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