ViVitro Analysis: Impact of FDA Program Alignment

January 10th, 2017

By Vesna Janic, Director, ViVitro Labs QA/RA

The FDA reorganization announced a while ago seems to be finally shaping up this year.  The main goal of the Program Alignment is to better coordinate field inspections with product reviews from FDA research centers and to identify companies that need more frequent inspections based on the poor state of their quality.  In today’s global market, and due to limited FDA resources, the hope is that more risk-based inspection planning and collaboration with foreign agencies will eliminate duplicate inspections and make compliant manufacturers’ lives a bit easier through less frequent visits as a reward for exceeding QMS requirements and running high quality operations.

Logistically, under the Program Alignment plan the 5 regional Offices of Regulatory Affairs (ORA) will be dissolved and replaced with commodity-based and vertically integrated inspection programs for drugs, biologics, medical devices, tobacco products, food and bioresearch monitoring that will operate from 20 FDA district offices. Commodity-based teams will have specialized investigators with technical expertise and adequate training in their field of expertise.  For medical device companies, this means they will be inspected by investigators who are not only  specialized in medical devices with in-depth knowledge of Quality System Regulation (QSR) and the intricacies of manufacturing devices, but the investigators will also have a sub- specialty in their particular product.  This will have huge impact on the quality of an FDA inspection compared to the previous practice where a company could be inspected by an investigator with a background in food, tobacco or pharmaceutical products.

As with any change, the question remains if the FDA will be less effective initially while figuring out how to align 5000 FDA investigators into different review programs while developing new inspection protocols. 2017 may be tough for both the agency and inspected facilities, however my belief is that all manufacturers in good standing with the agency will benefit from less frequent inspections and will enjoy working with investigators that are specialized in their commodity. This new approach should positively impact product quality and patient safety.

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