NSF International •Supplier Audits for GMP and Product Success 1 naturalproductsinsider.com

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Supplier Audits for GMP and Product Success

Good manufacturing practices (GMPs) were established in the Dietary Supplement Health

and Education Act of 1994 (DSHEA) and, in 2010, were legally required for all dietary supplement manufacturers, packagers and distributors that sell products in the United States. However, as demonstrated by warning letters and Form 483s issued by the U.S. FDA following GMP facility inspections, some supplement companies are struggling to meet requirements of the regulations.

Qualifying suppliers of components that will be used in dietary supplements is one aspect of GMPs that has proven to be a difficult challenge for many in the supplement business. However, that doesn’t make supplier qualification any less of a requirement.

Under the U.S. dietary supplement GMP regulation 21 CFR 111, supplement manufacturers are required qualify their suppliers; suppliers themselves are not governed under the supplement GMPs, but they still must meet food GMP requirements. In many supplier/manufacturer partnerships, suppliers often provide a certificate of analysis (CoA) that outlines the specifications of a component. However, manufacturers cannot rely on CoAs as their “qualification” under GMP regulations.

Per the FDA, CoAs need to be verified through tests run by the manufacturer, and those test results must be documented. Further, suppliers must be periodically requalified, and quality control (QC) personnel must review and approve the basis for qualification (and requalification) of suppliers. During FDA GMP inspections, the agency will request to see a manufacturer’s documentation of how suppliers are qualified.

In short, supplier qualification has two parts: auditing and testing.

“Inspections are showing that companies aren’t aware of the materials they are purchasing, or how to test and qualify them properly,” said Edward Wyszumiala, General Manager for Dietary Supplements Programs at NSF International. “In many cases, companies are still solely relying upon the supplier’s CoA and specifications, which, if used alone, will not comply with the GMP requirements.”

And if a company fails to qualify suppliers—and thus fall short of GMP regulations—it’s likely it will receive a Form 483, which is issued after inspections when the FDA finds GMP observations. An FDA warning letter may follow, which will show up on the FDA’s website and could discourage consumers from buying that company’s products.

Looking at the FDA’s warning letters to dietary supplement brands shows citations to companies for failing to qualify their suppliers and conduct appropriate testing.

For instance, Sterling USA Neutraceutical Lab received a warning letter from the FDA in November 2012 for not qualifying suppliers or validating the reliability of CoAs, among other GMP violations.

July 2013

If a company fails to qualify suppliers—and thus fall short of GMP regulations—it’s likely it will receive a Form 483, which is issued after inspections when the FDA finds GMP observations.

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A similar story was told in a March 2013 warning letter to Finemost Corporation (DBA Qualiherb), a dietary supplement manufacturer that received supplier CoAs for components used in its supplements; however, the FDA cited the company for not reviewing the CoAs or qualifying suppliers.

These are just two examples of an issue facing many supplement companies. While none of the GMP requirements are effortless, qualifying suppliers seems to be a more daunting task than other obligations. Supplement manufacturers looking for the best quality and return on investment (ROI) may source their ingredients all around the world. China and India are particularly popular places to source ingredients, but many natural ingredients are also harvested in South America, Scandinavia, the middle of the ocean or Australia. Even products sourced from the United States may not be easily accessible to manufacturers with facilities in America.

If a manufacturer were to audit each of its suppliers itself, it could mean many airplane tickets, a lot of personnel training and the development of a uniform system to qualify suppliers of different types of ingredients. The task could easily become so burdensome that a manufacturer would decide to limit its operations, losing market share.

“If a company wants to audit all of its suppliers, it needs to make sure it has a budget and team of inspectors ready to travel anywhere and everywhere,” Wyszumiala advised. “For the average manufacturer, it could be looking at

between 100 to 1,000 suppliers, depending on the scale and scope of production and raw materials being sourced.”

NSF’s Audit Tool Streamlines Supplier VerificationThis burden, along with the need for safer,

quality supplements, prompted NSF International to create an ingredient-specific auditing tool. This program, a part of NSF’s greater GMP certification, provides supplement manufacturers a uniform system to qualify dietary ingredient suppliers using a graded audit report. NSF’s program offers a faster and cheaper qualification than most companies could do on their own; plus, NSF’s auditors are specifically trained for the verification task.

NSF’s auditors are based around the world, so it’s easier from them to visit suppliers no matter where they are. “NSF has trained and calibrated auditors globally, where we can inspect facilities with local resources that are trained and calibrated,” Wyszumiala said. “Partnering with NSF helps to keep down costs and effectively manage the daunting task of supplier qualification.”

NSF’s supplier audit program includes an on-site inspection every six months, fulfilling the FDA’s requirement that suppliers are periodically requalified.

Supplement manufacturers looking

for the best quality and return on

investment (ROI) may source their

ingredients all around the world.

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The program’s standards are based on requirements from 21CFR 110 (GMPs for food manufacturing), the Food Safety Modernization Act (FSMA), hazard analysis and critical control points (HACCP) and additional important requirements including traceability and recall processes. “The NSF program also incorporates certain parts of the supplement GMPs to ensure the ingredients are being manufactured to the strengths they are claiming and to confirm purity of the materials,” Wyszumiala said.

This combination of standards helps supplement manufacturers rest assured that they are meeting the GMP requirement of verifying suppliers.

NSF’s worldwide auditors undergo robust training and qualification before they are allowed to perform inspections. They must also have the relevant background, education and knowledge. As part of their training, potential auditors perform several shadow inspections with an already qualified auditor and write corresponding reports to verify their competency and abilities to perform an inspection. In addition to initial qualification, NSF has an annual auditor training and calibration meeting for all of its auditors, and performs additional training and calibration when regulations change, or if new trends emerge from FDA inspections.

To fulfill the second part of the qualification, testing, NSF has two testing facilities available for dietary supplements and ingredients. At NSF’s U.S. and Chinese testing facilities, an extensive array of instrumentation, technologies and dedicated staff offers a variety of tests to ensure ingredient identity.

The NSF Shanghai Testing Laboratory complements NSF’s existing certification services in China while providing companies with a means to source safer products, raw materials and ingredients from Asia through independent, third-party testing and certification.

Further, NSF’s laboratories are designed to solve testing complications that often arise with supplements and dietary ingredients. Along with NSF’s analytical capabilities, it offers specified customer management, which enables NSF to solve validation method challenges.

Aside from method development, NSF also offers mainstream testing services, such as contaminant testing, banned substance testing and ingredient identity testing.

The supplier auditing tool provided by NSF allows manufacturers to qualify a supplier quicker, and use NSF’s resources to better focus on problematic suppliers, which decreases costs and increases ROI. And keeping down costs allows manufacturers to use their resources for what they do best: manufacturing and marketing quality products.

For more information on NSF’s ingredient supplier auditing tool, email dietarysupplements@nsf.org.

Keeping down costs allows manufacturers to use their resources for what they do best: manufacturing and marketing quality products.

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