Blog

News

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations quantify the differences between their real-world operations and the compliance rules that govern them. For instance, regulated firms commonly compare their standard operating procedures (SOPs), operating records and regulations to learn precisely how they vary.

A gap analysis is particularly useful when one must compare three geographically different company locations, which employ the same methodology, for example, in development and uses the same computer systems across the three sites.

In such a case a gap analysis against FDA requirements for GMP and perhaps GCP may be appropriate. Should electronic records and / or signatures be in use then one must also consider 21 CFR Part 11. Finally, one must also consider industry best practices such as GAMP 5 and the appropriate GAMP Good Practice Guides.

In this manner it is possible to construct a questionnaire, which is constructed in a way to show possible gaps in practices between the three sites. Thus it would be possible to harmonize the methodologies used in all three sites.

Although gap analysis is an effective means of identifying deficiencies, it’s also critical to put the information such assessments generate to good use.

What Makes Quality Management Work?

Good quality management isn’t only about learning where your problems lie; you also have to take steps to correct them. By comparing both your real-world performance data and your SOPs against regulations, your gap analysis may ultimately become more effective.

For instance, a firm may discover that some aspects of its products are massively out of alignment with a specific FDA regulation. If said firm also analyzes its SOPs thoroughly, it may discover procedures that don’t precisely match up with FDA suggestions. These could potentially contribute to the outstanding product issue.

If, on the other hand, the firm only analyzed its operating history in relation to FDA rules, it might have a difficult time zeroing in on the cause of its compliance problems.

Quality management strategies that incorporate comprehensive outlooks are often better at handling issues in real time. For companies that manufacture high-volume batches of products such as pharmaceuticals, being aware of standards and closely monitoring deviations through consistent gap analysis may make it easier to meet compliance goals and preserve product viability.

Gap Analysis and Other Techniques

Some firms combine FDA gap analysis with other techniques to improve their function. Suppose you already employ process mapping to clarify the compliance needs associated with complex projects and operations. In such a case, creating a gap analysis system where the data fits into the process map could be a great way to visualize how your compliance deficiencies impact one another and your operation as a whole.

Such interaction works both ways, as gap analysis may itself require complex actions to measure and classify deviations. For instance, your attempts to identify gaps between FDA 21 CFR Part 11 and your electronic record-keeping applications could require you to take multiple steps and check numerous features intrinsic to the software in question.

Applying the same process mapping strategies you’d implement for a manufacturing flow to your gap analysis procedures may make it easier to verify that you’re satisfying your regulatory responsibilities without missing steps as you go.

What Kind of Gap Analysis Is Right for Your Firm?

There’s no one-size-fits-all solution to FDA gap analysis. In order to keep such strategies relevant to their business models, companies generally have to customize their implementations and target specific parts of their processes for continued improvement.

Your manufacturing strategy may not be bound by the same regulations as the next firm’s, so it’s absolutely essential that you modify your compliance strategies to match. 

With GxP-CC consultants, you can learn to implement gap analysis techniques that actually work for your operation. Discover how to learn more from the results of your compliance efforts by contacting these experts today.

 

About this author:

Avatar

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.

Leave a Reply

Your email address will not be published. Required fields are marked *

*