Lack of adequate quality control personnel has become a more common feature of FDA warning letters in recent years. FDA has cited companies both for not having a QA staffer present at key junctures in the manufacturing process and has also started to look at the resumes of people that companies put forward as their QA team. Smaller companies may struggle both to identify the right people to hire and to attract that kind of talent in the first place in what in recent years has become a climate of scarcity for qualified QA staffers.
Ingredient Identity’s CEO Brandon Griffin said the company’s new program can help small companies bridge that gap. Finding the right people for these jobs, and building the right infrastructure to ensure efficient and consistent performance by them requires exceptional planning and investment by employers. Griffin said the new program, called its Outsourced Quality Assurance (QA) Solution to allow for plug-in-play remote quality program oversight to ensure day-to-day compliance of clients’ quality operations. Small organizations are the primary target, but larger companies that routinely contract such personnel from temp agencies, could benefit from the new program, too, he said.
“It’s primarily targeted at the small, virtual company that are supposed to have a qualified QA person on staff. A lot of times what we find is that they don’t,” Griffin said.
“On the opposite side, what we sometimes see is that larger companies that might go through a distribution spike (like a big product launch, for example), they need to hire quality control personnel but they might only need them on a seasonal basis, to release product,” he said.
Six month contracts
Griffin said the new program is set up for initial six-month contract runs, with the time the personnel are available capped at 40 hours per month. Most of the consultants’ time would be spent in virtual communication, but periodic on-site visits could be negotiated as well. Griffin said that low bar is a starting point for some of the smaller organization’s the tool is meant to serve, and additional levels of service could be added for more complex or challenging QA scenarios.
One aspect of the program that Griffin said he believes sets it apart is the web portal aspect of the offering. The web-based project management system enables real-time client access for all work output by the assigned quality and regulatory specialists. The staff and customers can interact and access information securely through remote system, which allows for increased transparency, traceability and reporting, inclusive of certain documentation control controls. This also concentrates the higher-priced QA staffer’s work where it's most needed, and could download some of the lower-skill parts of the job onto a lower-paid employee.
“The client might have an administrative person designated to collect and upload documents,” Griffin said.
The new program should alleviate a couple of the complaints of new entrants to the dietary supplement business, especially those running ripped-to-the-bone organizations distributing through online channels, those being that it is too expensive to fully comply with FDA regs on quality control and the agency has left the definition of who would be considered a qualified QA staffer too open ended. Griffin said Ingredient Identity has fully qualified people on staff, and the way the program is structured has made it as cost effective as possible.
“If somebody can’t afford this they probably shouldn’t be in business,” Griffin said.