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Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers

March 21st, 2014 by

FDA Mock AuditFDA and ISO inspections are extremely stressful, but they play vital roles in your market viability. Even if you don’t fail outright, you may find your firm on a watch list that makes it harder to win consumer trust or gain mission-critical investments.

To avoid such potentially debilitating outcomes, many firms solicit FDA mock audits from third-party compliance consultants. There are different forms of quality management services for a host of regulatory standards, but let’s touch on some areas to gain additional insight on audit preparation in particular.

What is Audit Preparation?

Audits and inspections follow a predefined format. For instance, during inspections that fall under the umbrella of the FDA’s medical device Quality System/GMP Regulation, inspectors must gauge whether manufacturers have instituted and followed required written procedures and documented evidence of the accuracy of these procedures. Furthermore, firms must provide documented evidence that they have their production processes under control at all times.
Because inspections are somewhat formulaic, it’s possible for device manufacturers and other biotech firms to prepare themselves through thorough self-evaluation. By focusing on the same areas of interest that FDA inspectors will zero in on, these companies may increase the likelihood that they’ll pass their audits. Learn more about satisfying FDA compliance guidelines by reading this article.

Assessing Your Own Deficiencies

Unfortunately, many manufacturers lack the prior experience to prep their operations for upcoming audits. Companies that haven’t established predicates for their past devices because they’re marketing novel technology, for instance, don’t really have a starting point for improving their standards and bringing them into alignment with FDA regulations.

Established firms, on the other hand, may have grown to the extent that they’ve let things get out of control; their deficiencies could include the control of factors, which have become so commonplace that they have been simply missed along the way.

This is where the mock audit comes into play. Mock FDA audits are conducted using the same standards that regulatory inspectors apply, and they’re often performed with increased diligence. By going over every pertinent detail that might cause issues in advance, life sciences companies gain a more intimate understanding of what they need to improve in order to pass the actual inspection.

Firms don’t have to wait until they receive an FDA announcement to prepare for inspections. Many companies that believe they’re overdue for state or federal inspections perform mock audits to be ready just in case.

Implementing Improvements In Operating Procedures

Once a mock audit is complete, companies can institute new standard operating procedures specifically for FDA audits. For instance, device manufacturers may choose to create basic departmental checklists that help each of their manufacturing teams ensure they’re operating FDA-compliant workplaces and perform self assessments in specific areas of concern. Some firms even go so far as to help their employees study the kinds of questions they may be asked or learn how to interact with inspectors in a respectful manner.

Mock audits provide firms with advanced feedback that helps them reduce the workplace stresses and potential losses associated with actual inspections. In addition, training employees to create copies of requested documents and attend inspector debriefings may make it easier to respond to FDA Form 483s if any are issued. Finally, mock audits can help companies improve their routine procedures and implement more compliant CAPA systems that prepare their products for markets around the world.

GxP-CC is comprised of industry-recognized compliance experts who help firms in the medical device, pharmaceutical and dental lab industries work through compliance challenges. Contact them today to discuss your needs to meet the regulations set forth by governing bodies.

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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