Uniform Standards Needed for Third-Party GMP Audits

What if 500 mg of vitamin C meant something different to everyone? What if scales weren’t regularly calibrated to ensure that 500 mg at one manufacturer meant the same thing everywhere else? What if one supplement claiming to contain 500 mg actually had 200, and another contained 800? If we didn’t have a universal understanding of the measurement and a way to ensure we are all measuring the same thing, products could end up being vastly out of specification, with potential health consequences for our supplement users. Thankfully, we all agree what a milligram is.

In a sense, that collective agreement has not been happening in the dietary supplement industry due to the lack of a common understanding of the GMP (good manufacturing practice) regulations. June 24, 2016, marks the sixth anniversary of the fully effective date of the GMPs for dietary supplement manufacturers found in Part 111 of the federal regulations. Yet, the manner of implementing those requirements varies greatly from one company to another. Although FDA says almost 6,000 domestic dietary supplement-related firms are registered with the agency under the Food Safety Modernization Act (FSMA), for the last two years, FDA has inspected fewer than 500 of these facilities each year. At that rate, it will take the agency more than 12 years to get to every facility that is registered today. So if we are expecting mere inspections alone to impose a uniformity on our understanding of the requirements, the industry is in for a long wait.

Increasingly, responsible marketers and manufacturers are looking to a reliable third party to conduct a mock inspection of their facilities and provide outside verification that the plant is operating at GMP levels. And an array of third parties are stepping up to fill the void, with many offering their own seal or stamp of approval that the facility is “GMP certified."

When a company invests in this exercise, it expects that a passing grade essentially answers this question in the affirmative: If FDA walked into your facility tomorrow, would it likely pass the government’s requirements for GMP compliance?

Third-party certifiers create one way of ensuring standards. However, in many situations, standards and expectations vary widely from one auditing firm to the next. A company could pass one auditor’s requirements and the next day fail the supposedly same scrutiny of another. What one auditor may find qualifies as an appropriate identity test or a sufficient qualification of a supplier—both explicit requirements of the GMP rules—might not pass muster with the next auditor. It’s sort of like having scales in various factories that disagree on what is 500 mg of vitamin C. We need to standardize what these third-party inspectors are looking for to increase the likelihood that when FDA does come knocking, the firm can be certain it will “pass" the FDA’s official inspection.

The industry needs to establish a common measuring stick for GMP inspections so that all reputable third parties are auditing GMP compliance to the same (or at least very similar) levels. Putting all manufacturers on common ground during these audits will help lower the prospects of receiving a “483" notice of violation from FDA and, more importantly, help ensure that dietary supplements, regardless of who manufactures them, carry an acceptable level of quality.

A common scorecard for GMPs has other benefits, too. In the wake of the New York attorney general’s investigation last year and the swelling attention from class action attorneys, a widely agreed upon metric of what constitutes GMP compliance can help persuade these industry-watchers that their scrutiny is misplaced. At the very least, it could push the focus and attention on the true outliers who choose to ignore their GMP obligations completely. Having endured a rigorous third-party review will demonstrate the industry is effectively self-policing—at least for those companies that pursue a third-party certification.

Retailers are also asking more exacting questions about the products they choose to put on their shelves—and demanding verification that the supplements they sell are “the real deal." Recent enforcement actions by FTC, FDA and state attorneys general have illustrated that retailers are not immune from investigation if they fail to exercise due diligence with their vendors. A standardized GMP measuring stick will help them evaluate which products are worthy of their customers.

Of course, the ultimate beneficiaries of a uniform standard for third-party audits are consumers. When they see a “GMP certified" seal on the label of a supplement, they will have increased confidence that the product was indeed manufactured under the strict requirements of the GMPs. A uniform standard will help consumers make informed decisions and support products that are making investments in quality that the GMP regulations were designed to incentivize.

Several efforts are currently underway to make this common measuring stick for GMP certification a reality. The Global Retailer and Manufacturer Alliance (GRMA), a group representing both manufacturing and retail interests, is working toward consensus of what the GMPs demand. The industry trade associations are offering support to this effort, and CRN, in particular, has pledged to help move this effort forward. It’s heartening to see competitors in the third-party certification arena, like NSF International, U.S. Pharmacopeial Convention (USP) and Underwriters Laboratories (UL), coming together to help raise the bar for industry.

It can’t happen soon enough. Today, quality and compliance go hand in hand. It’s not enough to say you make a quality product—anyone can say that. More consumers and retailers are looking for tangible confirmation that manufacturers are walking the talk. A common measuring stick for GMP compliance will allow everyone to know the value of a third-party audit investment. Just like the scales we use to weigh out ingredients, the standards for compliance should assure our consumers they are getting exactly what they expect.

Steve Mister is the president/CEO of the Council for Responsible Nutrition (CRN, crnusa.org), a trade association for the dietary supplement and functional food industry.