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The Importance Of GMP Compliance

GMP and cGMP Compliance

DaVinci Laboratories
Quantum University


In essence, the Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule 21 CFR Part 111, issued by the Food and Drug Administration (FDA) June 2007, requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling and holding operations. The move was supposedly in response to concerns about substandard dietary supplement manufacturing practices, as well as mislabeling practices, but more to the point, the rule was something the industry itself had been pushing for, according to an article on Dietary Supplement Information Bureau™’s website.

“GMPs have really been such a part of what we as an industry have been asking for for so long,” said Daniel Fabricant, vice president of scientific and regulatory affairs with the Natural Products Association (NPA, Washington, DC).

While quality and safety are two major criticisms of the natural products and dietary supplement industry, It was actually way ahead of the FDA when it came to GMPs.

According to Michael Lelah, technical director of NOW Foods (Bloomingdale,

IL) , in 2000, NOW was one of the first companies certified through the NPA, which has been certifying companies for just over 10 years, because “at that time, the NPA was the sole certifying organization in our industry. It developed its program in response to the glacial pace of the FDA’s issuing GMP guidelines,” he said.

The FDA’s proposed regulations were published in 2003, but the final regulations weren’t passed until June 2007.

The final GMPs were effective in June 2008 for large companies (with more than 500 employees); companies with less than 500 employees had until June 2009 and companies with fewer than 20 employees have until June 2010 to comply.

As Lelah explained, the implementation strategy set forth by the FDA was made purposefully. “The phase in was intended to give smaller companies, which were less likely to have GMPs already in place and have less resources, more time to prepare,” he said. “It also means that now there is a level playing field, with all companies required to meet the same basic guidelines in manufacturing.” “With the quality burden placed solely on the manufacturer, this was a major wake-up call for many companies that had not made a prior major investment and commitment to dietary supplement product quality,” said Travis Borchardt, vice president of regulatory affairs and QA/QC with Schwabe North America, parent company of Enzymatic Therapy (Green Bay, WI) and Nature’s Way (Springville, UT).

But more importantly, the new GMPs, according to Kate Jones, vice president of Nutrition Now, Inc. (Vancouver, WA), are significant in improving the industry’s reputation.

“The new GMPs are critical in bolstering consumer confidence regarding dietary supplements,” said Jones, whose company has been serving the industry for 25 years and has been certified by NSF and NPA. “It helps to legitimize the quality work that reputable companies do to put out high quality, safe dietary supplements.”

NPA Led the Way

Well before the FDA put forth its final regulation, NPA already had a program in place that created a quality standard for the industry.

“Before FDA finalized part 111, we had our own program, which is really industry best practices,” said Fabricant.

“Everything in the federal GMP is included in our program, so when the final rule was posted, it was a pretty seamless transition.” There are, however, a few additional requirements for NPA that exceed the federal rule.

“First, we require expiration dating, which is not required by federal GMPs,” Fabricant added. “Second, because of our experience going into so many facilities after 10 years, we require a dedicated quality unit—that’s the sun that everything revolves around and we want to see it in their facilities.” Through the NPA’s program, finished product manufacturers must meet all the new FDA dietary supplement cGMP applicable regulations, all the food cGMP regulations, the Serious Adverse Event Reporting (AERs) regulations and other regulations specific to their products.

These rules and obligations cover the manufacture, packaging and distribution of dietary supplements.

Yet attaining NPA’s GMP certification isn’t the sign of a great manufacturer as much as maintaining it is, according to NOW Foods’ Lelah.

“GMPs are not just about meeting the requirements for the inspection. GMPs must become a way of life, repeated every day so that every single item purchased by a customer at any time is manufactured to these same standards,” he said. “The NPA and other certifying bodies re-audit the facility every two years on an ongoing basis to maintain certification.” And the NPA’s reach is considerable.

“About 70 companies are certified right now, and when we certify a firm, we cover all the buildings in an operation (some companies have 10 separate facilities). It’s a lot of buildings, but 70 companies have certification on four continents,” said Fabricant. “The FDA estimates there’s about 56,000 products total. The last time we did a survey, our GMP-certified companies represent about 25,000 products, so we have pretty good coverage of the industry.”

Third Parties Bridge Gaps

While safety may be an unfounded fault lumped on the dietary supplement Industry as a whole, an equally large criticism of the FDA is that it doesn’t have the resources to do the tasks before it. That’s where third-party certifiers like NSF International (Ann Arbor,

MI) come into play.

“FDA has ramped up their efforts in the area of dietary supplement GMP inspections, but still lacks the resources to aggressively inspect all companies in the industry in a short period of time,” said Borchardt. “Companies like NSF International help to bridge the gap by inspecting companies versus the new GMP standard and issuing certification to those companies that are in compliance.” Similar to the NPA’s program, according to Ed Wyszumiala, general manager of NSF International Dietary Supplement Certification Programs, the NSF program, which was created in 2001, was designed to be reflective of the FDA’s GMPs for the dietary supplement industry.

“In addition, the NSF audits also verify that the company has registered pursuant to the Bioterrorism Act of 2002, that they have an AER reporting system and structure to handle potential AERs that are submitted, and that the facility has documented recall procedures in place,” said Wyszumiala.

“Being an ANSI (American National Standards Institute)-accredited certifier to the American National Standard for Dietary Supplements, ANSI Standard 173, we had to take the appropriate steps to propose the changes to the standard to fully encompass the new regulation,” he added. An issue paper was proposed and passed by the Joint Committee which oversees the national standard to change Section 8 of the standard from the proposed regulation to mirror the language as defined in 21 CFR 111.

To be GMP certified by NSF, a company is audited twice annually. This includes a full two to four day inspection, depending on the size and scope of the facility, followed by a one day monitoring audit six months after the full inspection. A company also has to address any corrective actions found during these inspections submit Responses and have these approved before certification is issued. To keep the certification, the facility must continue to pass the annual inspections and address any corrective actions that are found during the inspections.

And like NPA, NSF’s coverage of the industry is considerable.

“Currently, NSF has certified 186 facilities globally. This number has grown dramatically since 2007 when NSF only certified 53 facilities. This growth can be attributed the completion of the final GMP regulation, as well as NSF increasing its global capabilities by opening up new offices and calibrating new auditors and staff in China, India, Southeast Asia and in Europe,” said Wyszumiala, who added that NSF currently has another 60 companies working through their corrective actions from their initial audits moving closer toward certification. “For every facility we audit, there are corrective actions found. And for every corrective action we address with those facilities, NSF helps these companies to minimize their risks and help them strengthen their quality controls and procedures. Essentially, NSF helps these companies produce a product that is consistent and of the highest quality, which should help raise the overall perceptions of the industry.” Enzymatic Therapy is one company that thoughtfully chose NSF’s certification.

“NSF International was chosen because they are well respected and recognized by industry, customers and regulatory bodies (such as FDA),” said Borchardt. “We acquired NSF certification to satisfy requirements set forth by certain customers and to facilitate communication to the general consumer that our facility is in compliance with the new Dietary Supplement GMPs.”

Customer is Always Right

While the industry has had good manufacturing practices at its heart, the public declaration by the FDA confirmed for skeptical consumers that there is a government body overseeing dietary supplements.

But in actuality, it was the retailer—the manufacturer’s customer— and, in turn, consumers themselves who were most vocal about requiring GMPs.

Take Nutricap Labs (Farmingdale, NY) as an example.

“From when we first started Nutricap Labs in 2003, we knew there had to be a standard set in the industry and wanted to ensure our customers would always receive the highest quality product,” said Jason Provenzano, the company’s executive vice president.

Nutricap Labs attained certification with NSF International and NPA as well as became FDA-registered and Quality Assurance International (QAI) compliant.

“We wanted to make sure that in the event our customers’ requested verification that our facility was certified. We can also provide copies of our certificates upon request.” “When you look at the companies who have been doing it for a while and incorporated GMPs from the start, for them this process was nothing,” explained Fabricant. “But for other folks, especially those where the retailer was demanding it, saying ‘this rules out here and for our liability purposes, we’ve got to have assurances,’ that was a deciding factor and really pushed manufacturers. That’s going to help for the future.” And the end goal, of course, is to make sure that consumers are confident with their purchases while insulating retailers.

“Certification helps to ensure manufacturers produce safe, high-quality, unadulterated and properly labeled dietary supplements,” said Nutrition Now’s Jones. “Consumers will, in turn, have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled, which will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity, purity, strength and composition.” “As a trade association, we’ve spent a great deal of time educating our retailers on what it means to be GMP certified,” said Fabricant. “For example, ask someone behind the counter at CVS ‘what’s a GMP?’ and they have no idea.

Walk into a health food store and those retailers have the knowledge. The message is out there and I think people understand it. You have the technical side of it, but I think the firms that are GMP certified have done a great job of making it the platform for their sales and communicating it to the retailers.” Continental Vitamin Co. (Vernon, CA) agrees that GMPs offer assurances to retailers, but William Swan, the company’s vice president of operations, also expressed that retailers still have to be careful when choosing products to stock.

“GMP certifications mean to retailers that a company has checks and double checks for purity and quality of products,” said Swan. “But when retailers are vetting products, they should research the companies that they deal with—they are ultimately responsible to their customers.” “Many companies claim to be GMP compliant and have logos and statements stating such, but they can amount to nothing more than marketing spin,” said NSF’s Wyszumiala. “Retailers should always ask companies to demonstrate their GMP compliance.” Having GMP certification is essential, but as Nutrition Now’s Jones expressed, the process is ongoing. “We recognize that product safety is not a static process,” she said, “but a continual one that can always be improved upon.”

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