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Is It Time for Your Firm to Undergo an FDA Mock Audit?

January 19th, 2015 by

FDA Mock AuditAmong compliance tools, FDA mock audits are undeniably useful. By giving GxP-regulated organizations the chance to see how their operations would stack up against real-life inspectors, they make it easier to target and solve outstanding issues. Nonetheless, mock audits don’t have the same benefits for every firm that uses them; in some cases, they may even be more appropriate for certain organizations than others.

So how does a firm determine whether mock audits are right for them? For many, the decision boils down to assessing quality management systems in the context of specific regulations, while other companies may have to rely on their past experiences with regulatory bodies. 

Holding Your Operations to a Common Standard

FDA mock audits aren’t just for firms that want to adhere to U.S. regulations. The mock audit process can be applied to a diverse range of guidelines published by the European Regulatory Authorities, ISO and LRQA, so these exercises are generally appropriate for companies that want to attain universal compliance.

Furthermore, many international regulations exhibit some minimal amount of overlap. Self-aware mock audits that take these common factors into account may provide superior results by minimizing repetitive assessments or identifying ways in which compliance systems could be pared down to increase their efficiency in the future.

If you’re currently working to master harmonization processes through ICH or other guidelines, for instance, a targeted mock audit could be a good way to get a feel for your progress.

Overcoming Prior Failures Effectively

The need for mock audits may be predicated by an inspection failure or the receipt of an official Warning Letter. While it’s certainly a smart idea to put your post-warning improvements and modifications to a rigorous test, you should always maintain awareness of the fact that you can’t be narrow-sighted in your use of audit techniques.

The outstanding issue that earned you regulatory disfavor may have been related to a larger overall problem, but there’s no guarantee that the inspector who identified the deficiency actually noted its cause. If your mock audits focus only on the weaknesses you know of, they could lose their ability to help you overcome past mistakes. In short, although mock audits can help most organizations, they must be applied correctly to matter.

Instituting Workable Quality Risk Management Standards

As your firm applies quality risk management tools and performs reflective exercises like mock audits, it’s essential that you implement standards that you can maintain. Mock audits can be as involved as their real counterparts, and although periodic exercises are pretty useful, they shouldn’t really be a daily occurrence. 

Before deciding it’s time for a mock audit or similar exercise, it may be wise to consult with an expert about the most useful application of such techniques. With decades of real-world experience, GxP-CC staff have learned to assess the needs of modern firms and determine exactly how and when to apply FDA mock audit techniques for the maximum benefit.

Furthermore, GxP-CC has shown that through the correct application of mock audits as a tool, it is possible to implement measures, which in many cases may help avoid regulatory dissatisfaction with your quality management system and its associated processes.

Learn more by contacting the GxP-CC professionals today.

 

 

About this author:

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Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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