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How to Ensure Your Firm Meets FDA Compliance Guidelines

February 25th, 2014 by

Pharmaceutical Manufacturing InspectionFDA compliance is obviously a pertinent issue for many life sciences firms. In addition to helping firms protect their consumers, compliance improves profitability. For instance, the FDA can easily block non-compliant manufacturers from selling products or force recall actions.

In lieu of spending years and millions of dollars lobbying against regulations, most firms choose to supplement their operations with quality management systems. Click here for more information on what these implementations entail.

Determining What Your Firm Is Lacking For Compliance

There are numerous regulations in the US and in Europe that apply to both pharmaceuticals and medical device manufacturers; many of these can be found in FDA 21 CFR  210, 211 and 21 CFR 820, the European Medicines Agency, the ISO standards, such as ISO 13485 and other legislation. Although this information is freely available from government websites and other sources, searching these repositories is an inefficient way to flesh out your corporate compliance to-do list.

Instead, pharmaceutical and device manufacturers typically work with consultants who can help identify their deficits and provide processes for reaching FDA compliance. This is a widely accepted industry practice because it allows companies to get up to speed with standards and still focus on their specialties.

Training Staff To Better Meet Compliance Regulations

An experienced compliance consultant can identify weak points and poor or improper practices currently being used. The organization then can begin addressing and correcting issues in its methodologies and processes. One common way to do this is to have a specialist consultant perform a gap analysis on the basis of the appropriate legislation and then implement on-site training programs.

FDA compliance training allows employees to adapt how they perform in real-time. By working with consultants on-site, trainees learn to apply necessary compliance monitoring procedures and assessments to their jobs promptly and efficiently.

Rigorous Compliance Testing

Finally, remember that it’s essential to have implemented a rigorous and stringent change management to control changes within your organization and then to perform the necessary tests on the changes you have introduced. Hiring a consultant to perform a mock audit, for instance, is a highly effective way to see whether the new procedures you’ve devised actually perform as they’re intended.

These audits also serve as critical training should your organization be confronted with similar assessments by the FDA itself. By creating quality management systems and actually putting them through their paces, firms become increasingly accustomed to the very act of maintaining FDA compliance and implementing a program of continual improvement within the company. Such habitual familiarity goes a long way towards being able to adapt to new rules and/or processes.

GxP-CC offers compliance consulting to the medical device, dental lab and pharmaceutical industries. Contact them today to discuss your needs in order to meet FDA compliance for your product.

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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