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Improving CAPA in the Regulated Industries

May 29th, 2014 by James Francum

CAPA SystemCorrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to eliminate the cause of a detected nonconformity, or any other situation deemed to have adverse effects on a drug product. A preventive action (PA) is an action to eliminate the cause of any potential nonconformity, or other undesirable situation in the manufacturing process, or in the drug product itself.

Although individual CAPAs typically pertain to specific systems or issues, the companies that use them most effectively often implement comprehensive systems that manage CAPAs in general. Compliance consulting plays a big role in these firms' ability to create said systems, and it can be used within production facilities to identify a number of areas for targeted improvement.

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Qualifying CAPA Deficiencies

The FDA CFR 21 regulations that mandate CAPA systems make explicit mention of a number of requirements that CAPA implementation procedures must address. These include work operations, concessions and processes. However, firms are also responsible for actions pertaining to returned products, complaints, and a host of alternative data sources related to product quality.

In addition to demystifying the nature of FDA corrective and preventive actions, consultants may be able to help firms get a better handle on where their deficiencies lie. For instance, experienced consultants might help a medical device manufacturing company make better use of data analysis tools or identify statistical methodologies that could prove more effective in evaluating product non-conformance data. These kinds of analytical advancements are crucial to implementing systems that actually work correctly while remaining cost effective.

Performing In-Depth Investigations

There may be situations in which it can be difficult for firms to apply appropriately intense scrutiny to their own operations. Companies that try to evaluate their CAPA systems internally may discover that their inherent assumptions and predispositions work against them. If you believe that vital components of your methods function properly, for example, you may never investigate them thoroughly enough to discover the problems they really bear.

Impartiality is one of the vital components of good consulting. When an operation is assessed by individuals who approach evaluations from an outsider's perspective, inspections tend to be much more comprehensive. Because independent inspectors address the entirety of what they observe, they're less likely to miss vital issues, and they may be able to make suggestions with more insight concerning the correction of known problems.

Effectively Implementing CAPA

CAPA regulations are designed to be comprehensive. All the activities required in CAPA systems, for instance, must be documented, and the final results have to be tracked in a similar fashion. While there are numerous ways to implement CAPA systems, each individual solution needs to take a broad-sighted approach to oversight and data generation to really maintain compliance.

Oversight is crucial to implementing CAPA in the regulated industries because firms must gauge how well they're doing. A properly implemented CAPA system must take into account all aspects and fundamentals of the ‘Quality by Design’ and ‘Quality Risk Mitigation’ concepts. Furthermore, without these aspects and accurate performance feedback, GxP organizations that create CAPA solutions would be in direct violation of the rules.

The FDA states that CAPAs must be verified to demonstrate they're not having an adverse effect on finished products. By working with third party consultants who provide fresh viewpoints, improve understanding of vital data and perform valuable assessments, like FDA audits, GxP firms may be able to drastically better the way they devise and use CAPA procedures.

GxP-CC is one of the leaders in compliance consulting for the life sciences industry. Contact them to discuss their CAPA training program which is tailored to fit your needs and will help you to improve your overall Quality Management System.

Posted in CAPA, Corrective and Preventive Actions, FDA CFR 21, FDA Compliance Consultants, FDA & European Regulations, GxP CC, Quality Management System

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James Francum

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