SIDI Releases Voluntary Supplier Qualification Guideline

In an effort to create clear-cut standards in the dietary supplement industry, the SIDI (Standardized Information on Dietary Ingredients) Work Group released its voluntary Dietary Supplement Component Supplier Qualification (SQG) Guideline  on Jan. 17, 2013. The free 50-page document gives manufacturers a roadmap to qualify their suppliers and ensure safe, high-quality products.

Under current  cGMPs(current good manufacturing practice, 21 CFR Part 111.75), manufacturers must qualify their suppliers if they rely on suppliers certificates of analysis (CoAs). Supplier qualification boosts supply chain integrity, allowing manufacturers to trust their suppliers and therefore test materials less often. But there was one problem with the supplier qualification process, said Duffy MacKay, N.D., chair, SIDI Work Group Executive Committee, and vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN).

"FDA was never explicit in how a company goes about qualifying the supplier," MacKay said. "We realized people interpreted the meaning very differently."

Rather than wait for FDA to define "qualifying the supplier" and possibly issuing new regulations, SIDI decided to draft a standardized guideline. Led by CRN, the Consumer Healthcare Products Association (CHPA) and the United Natural Products Alliance (UNPA), the move encourages consistent self-regulation.

Drawing from the experience of 13 contributing companies and trade associations, SIDI created an outline manufacturers can individually tailor to their materials and needs. Though customizable, the guideline spells out a clear path to compliance:  "A responsible manufacturer uses a risk-based approach to qualifying suppliers," MacKay said.

As with SIDI's previously released tools (SIDI Protocol and CoA Guideline), the SQG document provides an actionable plan for companies. In eight chapters, the voluntary guideline leads manufacturers through the supplier qualification process, starting with supplier audit assessments, risk factors, CoA recommendations, requalification and disqualification considerations. From there, companies can determine component and supplier risk.

The guideline takes a middle-of-the-road approach to GMP supplier qualification, but MacKay noted the five-year writing process was an exercise in compromise. Some committee members felt SQG should have been a high-standards best practice document, while others believed it should simply discuss the minimum requirements of the law.

To meet in the middle, the committee identified best practices to be in complete compliance, while offering suggestions to manufacturers who wanted to go above and beyond. Consequently, smaller manufacturers can easily digest the action plan, and larger companies can streamline their own processes.

"This is not a one-size-fits-all supplier qualification criteria," MacKay said. "You can't say, 'For every single supplier, you must do X, Y and Z.' That's not a real-world scenario." Instead, he offered two hypothetical situationssourcing silica and probioticsoutlining the importance of customizing supplier qualification based on risk.

First, the inert ingredient silica has a low risk of contamination and spoilage. MacKay explained manufacturers can choose from major global suppliers with decades of experience and countless audits. Instead of sending an auditor there, manufacturers can simply request an audit report. If it's from a respectable organization, the supplier is low risk, requiring less attention and fewer resources.

Living probiotic strains, on the other hand, can spoil or lose their potency; the material itself has a different risk profile. "Now, imagine it's coming from a country that has a developing regulatory framework without regular inspections," MacKay said. "The manufacturer has to do a lot to make sure that supplier is doing things up to par."

One company can experience both of these situations. To tackle these variances, SIDI developed the SQG document with adaptation in mind, including customizable risk-assessment tools such as outlined steps, flow charts and examples. Whether sourcing a benign ingredient or investigating a new company, a manufacturer can ensure proper supplier qualification using the new guideline.

Though SIDI officially released the guidelines in January, the work group issued a draft in April 2012 for industry comment. SIDI also presented the SQG document to FDA, so the government agency is aware of the industry's voluntary self-regulation efforts.

So far, MacKay said, the industry reaction has been mixed.

"I would love to be able to say people are clamoring to get the documents and install them into their business model, but its a slow process," he explained, noting FDA's increased inspections have opened companies' eyes to compliance standards. But SIDI's goal isn't to revolutionize the industry's assessment methods. Instead, it hopes to lay the appropriate framework for qualification so regulatory agencies and industry are on the same pageleading to a more compliant market with higher quality products.

"In the best-case scenario, when inspectors are in facilities and ask, 'How did you qualify your supplier?' manufacturers will use this as a reference point," MacKay said. "The agents will have some comfort that the manufacturer has done it correctly."