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Demystifying FDA Corrective and Preventive Actions

February 6th, 2014 by James Francum

Corrective and Preventive ActionsRegulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with such actions take many forms, but they're of the utmost importance for maintaining compliance not only in the United States, but the European Union as well.

What Does CAPA Do?

CAPA systems help firms deal with existing problems (corrective actions) and head off potential issues (preventive actions). They also keep management informed about ongoing faults by setting standards for deficiency reporting and remediation.

FDA CFR 21's Part 820 mandates the rules for CAPA systems. This section notes that the procedures such systems include must evaluate processes, various records, work operations, concessions and a number of other quality data. In addition, firms need to use statistical methods to detect and identify the causes of production nonconformity and recurring problems.

The Impact of CAPA on Business Operations

Defective CAPA systems are commonly cited as being one of the primary factors in failed FDA inspections. Firms that neglect to verify and validate their corrective and preventive actions often experience difficulty convincing inspectors that they're adhering to applicable regulations and that their products are free of potentially hazardous defects.

All CAPA activities must be documented to retain validity. Although it's critical to adhere to the spirit of this regulation, it's just as important to maintain an organized system that lets your employees create the paperwork to prove their compliance. These records may also act as vital baseline data for optimizing specific processes.

Getting Up to Speed

FDA corrective and preventive actions must become an integral part of every step in your production and quality management system processes. If your CAPA system isn't tied to all of your control points, you're leaving your firm open to problems that you won't have the data to correct, let alone preclude any issues.

Of course, you can't simply implement CAPA systems indiscriminately. For these process structures to be profitable, they must facilitate solutions to problems in an efficient fashion. Visit this page to learn more about effective quality management strategies.

GxP-CC is an international team of leading compliance consultants for the medical device, pharmaceutical and dental lab industries. They are well-versed in US and European government regulations. Contact them today to discuss your compliance needs.



Posted in CAPA, Corrective and Preventive Actions, FDA CFR 21 Part 820, FDA Compliance Consultants, FDA & European Regulations, GxP CC

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James Francum

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