This is “absolutely the biggest challenge” facing dietary supplement manufacturers because company heads are usually not scientists and do not understand the intricacies of implementing FDA’s new Good Manufacturing Practices (GMP), said Aaron Secrist, director of quality at Nature’s Way.
Speaking at an advanced Natural Products Association (NPA) course on GMPs held at Supply Side West in Las Vegas, Secrist stressed the importance of communicating the message that the need to “hit the numbers” must be balanced with the need for compliance.
And at the center of that message needs to be a thorough understanding of the consequences of non-compliance.
ROI
“These requirements are the law; they are not merely recommendations or guidelines. CEOs need to understand that if you do something shady, FDA will come after you, and they’ll come after you hard,” he said.
Not meeting the necessary requirements could result in product recalls, product seizures, fines, injunctions, personal liability and even criminal prosecution.
Only a clear understanding of these consequences will drive home the importance of investing in additional staff, time and resources to ensure GMPs are properly met, said Secrist.
He stressed that the “end does not justify the means”.
“Just because the product meets finished product specification, it does not mean that you are in compliance.”
Gap analysis
The best place to start in this education process is the ‘gap analysis’ – looking at the regulations and at where a company stands against these. This then allows for an analysis of what needs to be done in order to close the gap.
This needs to be set out in a risk-based approach, so that management can understand what the company is likely to face if the gap is not closed.
Quality control employees need to communicate results of all internal GMP compliance audits, along with implications, action plans, timelines, responsibilities and resource allocations, said Secrist.
He suggested they create a ‘Top Five’ compliance vulnerability list that highlights the top compliance concerns: What they are, why they are important, and the likely outcome if remediation does not occur. This list must be regularly updated and communicated, he said.
“Upper management needs visibility; it is crucial in order to make sure you remain on track. It is important that progress towards completion of corrective actions, or remediation plans, is monitored and documented, and that failure to meet objectives or deadlines are addressed by management”.
“What we really need to do is try to get some of these CEOs to meetings like this, where they can actually hear it all for themselves,” he told NutraIngredinets-USA.com.
Secrist’s presentation was part of NPA’s day-and-a-half long Advanced Course on the Final FDA GMP rule for Dietary Supplements, which took place prior to the SupplySide West trade show this week.
NPA is at the forefront of GMP education throughout the dietary supplement industry, where it has been active since the GMP program’s inception in 1999.
In future articles, NutraIngredients-USA.com will examine Secrist’s tips on getting started on GMP implementation, and other challenges and considerations highlighted during the workshop.