Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it’s critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could result in a regulatory authority taking action against your company.

FDA Gap Analysis is one of the many strategies that companies employ to ensure that their efforts match up to their good intentions and goals. When combined with regular mock audit scheduling and other quality management methodologies, gap analysis can make a notably positive difference in how firms operate.

What Is Gap Analysis?

For all GxP firms do in order to maintain compliance with regulations and guidelines, there’s generally some difference between their implementations and the standards they strive to meet. Gap analysis lets companies quantify such discrepancies by assessing their compliance strategies from an impartial perspective and providing vital feedback data on where any faults lie.

Where Does Gap Analysis Data Originate?

There are numerous sources of data discrepancy, and one of the most common methods of finding these discrepancies is the self-audit. Internal and mock audits allow firms to evaluate their performance against a set of predefined benchmarks, such as those established by the FDA’s 21 CFR 820 Quality Systems Regulation. Such exercises are therefore immensely helpful when it comes to establishing the efficacy of a particular compliance plan.

As a mock auditor goes through the various facets and standards enumerated in a given regulation, each implementation enacted by the company in order to uphold compliance with a certain regulation can be judged in a step by step manner. At the end of the procedure, the firm is left with a list of deficiencies that need to be addressed in order to close the gaps.

Gathering Extra Data

Formal audits aren’t the only important gap analysis tools that firms can draw upon. Companies that implement technical frameworks and IT implementations, for example, may employ automatically generated feedback data to keep track of ongoing deficiencies while corrective actions are being taken.

Other organizations that receive potentially damning FDA warning letters may even be able to use such information to contest the allegations against them and demonstrate that they’ve made traceable changes.

Using Gap Analysis Results Effectively

FDA gap analysis procedures aren’t only helpful when attempting to maintain regulatory compliance. The very nature of proactive, regular gap assessments gives firms the ability to quantify their own internal standards, and this makes such assessments essential to efficient cost-benefit analysis.

The same gap analysis practices that a company employs following a mock FDA audit may be applied to any standard GxP operating procedure. By clearly identifying and quantifying the severity of discrepancies between their real-world activities and planned expectations, firms can discover whether they need to devote more effort to specific business practices. In the end, gap analysis is vital to continued business improvement.

GxP-CC is a leading compliance consultative firm helping today’s businesses comply with FDA and EU regulations and guidelines. Contact them today to find out how they can devise a strategic plan to help you correct gaps found within your systems and processes.

About this author:

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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