As consumers choose from thousands of different dietary supplement brands online and in-store, and regulators evaluate manufacturing operations, what are the essential components of quality systems that ensure product integrity?
“Accredited independent certification is the single best hallmark of a robust quality control system,” said David Trosin, senior director of global certification, NSF. “Certification confirms the claims a business makes are verified by a respected third-party organization.”
That validation from an outside source can offer consumers assurance, but a strong quality control system must begin with planning, Trosin added. “At a very base level we must ask, ‘are you aware of the rules and implementing them?’ If you don’t have a plan, you’re planning to fail. Cutting edge technology can be helpful, but sophisticated software isn’t required. In fact, a sharp mind, pen and paper can be the start of a robust quality program.”
Once a quality plan has been established, “organizations must ask themselves if quality is identified as an investment or a cost,” said Trosin.
“Questions such as this define how businesses think about quality at a strategic and operational level,” he added. “Companies that consider quality as an investment have the strongest, most reputable brands, while those that consider quality a cost that can be cut eventually suffer financial and reputational harm due to their piecemeal approach to quality.”
Documentation is another principal characteristic of resilient quality programs, said Trosin. Implementing change management to establish documentation as a standard operating procedure can be challenging, he added. “However, once it is in place, the question then becomes: how are you reviewing the documentation to track trends, make your team better, and elevate both issues and best practices as they arise?”
Creating a culture where change is embraced, not feared, allows organizations to continually improve their processes instead of reacting to problems, Trosin said.
“Foundations of a robust change management program are documentation, collaboration, and awareness. Data from the program should be used to improve processes, systems, and resources by tracking trends, elevating issues and best practices and exposing gaps where additional training is necessary.”
Dietary supplements companies have faced many challenges in recent years, including supply chain disruptions, which can significantly impact quality, noted Tom Lawson, chief science officer at Vitaquest, a New Jersey-based dietary supplement manufacturer.
“At Vitaquest, we ensure product and quality integrity through a comprehensive quality program that actively involves our employees at all levels,” said Lawson. “Our approach is grounded in the principle that the best way to ensure quality is to engage our people and have them take ownership of the products they create, at every stage of the process. That is the hallmark of a good quality system.”
“We utilize cross functional teams in our food safety program which incorporates members of all different operational departments,” he added. “We also have representatives from all areas of production take part in our internal GMP audits and inspections. This allows our production employees to be shareholders of the various quality initiatives and improvement projects.”
According to Len Monheit, executive director, Ingredient Transparency Center, robust quality systems start with in-depth knowledge of the supply chain and an understanding of the risk within it.
“This means knowing the suppliers with deep multifaceted relationships, having trust in them when shortages occur to be informed and take risk mitigation strategies. It means knowing likely impurities to test for and having a validated third-party testing system in place — also with trusted vendors,” Monheit said.
Advanced quality programs go beyond rule implementation to embed quality in the culture, Trosin added.
“In this scenario, we ask questions like: ‘how are you living it?’ ‘Have you created a culture of quality in your team?’ From the receptionist to the CEO, each person must be willing to do the basics like pick up trash, check for appropriate gowning and notice the opening and closing of doors are correct. Is that happening? Now that a plan is in place and you know how to live it out in your culture, you need to document, review and test the system. Testing can include everything from recall drills to continuing education.”
Holly Chang, vice president of technical services at USP, said dietary supplement quality systems must include controls for the manufacturing, packaging, labeling, holding and distribution of the dietary supplement. Processes, procedures and responsibilities need to be well documented and controlled.
Companies should have quality “baked into their processes and procedures,” she said, which can include:
- Compliance with USP General Chapter <2750> Manufacturing Practices for Dietary Supplements and FDA current Good Manufacturing Practices (21 CFR Part 111 & 117);
- Appropriate quality control manufacturing (QCM) product documentation; and
- Conformance to standards of quality found in USP-NF, or to appropriate pharmacopeial or manufacturing specifications.
“Adherence to good manufacturing practices and USP General Chapter <2750> Manufacturing Practices for Dietary Supplements ensures companies are vetting their suppliers and testing for contaminants as part of their quality control systems,” said Chang. “The USP Verification Program helps confirm these practices are in place and identifies gaps where criteria are not being met.”
Photo: yanadjan/adobe.stock.com
Meeting Label Claim
Alongside documentation and specifications, ensuring that a product actually contains what’s listed on the label — and nothing more — through the expiration date is an essential component of quality control and product integrity.
The best way to ensure a product meets label claims is to “be harder on yourself than anyone else would be,” said Trosin. “Test as if a class action lawsuit is in progress.”
Manufacturers can voluntarily participate in third-party verification programs, such as USP’s Dietary Supplement Verification Program, to confirm that what’s on the label accurately reflects what’s in the bottle, noted Chang.
“Dietary supplements that go through USP’s Verification Program are verified through a rigorous and comprehensive testing and evaluation process to ensure that what is on the supplement bottle is reflected on its label.”
To determine whether a product can receive the USP Verified Mark, USP conducts a manufacturing facility audit to ensure compliance with the U.S. FDA’s cGMP, along with a review of manufacturing and quality control product documentation.
“USP then tests samples of dietary supplements to confirm conformance to standards of quality found in USP-NF (or other appropriate pharmacopeial/manufacturer specifications) and conducts off-the-shelf testing of USP Verified products to confirm they continue to meet USP’s trusted science-based quality standards,” said Chang.
Brands need to have proper stability testing conducted to ensure dosage through shelf life, added Monheit. “Where overages are needed, ensure these are safe, and not simply a catch-all for poor manufacturing that allows moisture and oxygen to degrade the product. Brands have the responsibility for quality. Don’t outsource that to your CMO.”
“I don’t think you can outsource quality and it seems to me to be what amazon is trying to do. The current proposal puts document review on quality into a few hands, compromises existing vendor relationships and simply does not solve the problem while encumbering the system with both time and cost. And it doesn’t solve parts of the problem like counterfeit products. I am not impressed.”
— Len Monheit, Industry Transparency Center
Amazon Compliance Requirements
Earlier this year, Amazon announced new requirements for compliance verification of dietary supplements sold on its platform, mandating companies use one of three third-party testing, inspection, and certification (TIC) organizations to submit compliance documentation.
In the past, sellers were able to use certificates of analysis (CoAs) from any ISO 17025-accredited lab, or from in-house laboratories that were compliant with all cGMPs. Now, Amazon will only accept documentation directly from NSF, UL, or Eurofins.
Companies can still use ISO 17025-accredited labs, including in-house ISO labs, but sellers will need to submit testing information to one of the three TIC organizations Amazon has identified. These gatekeepers will validate that products meet Amazon’s criteria that:
- Products are manufactured in a facility compliant with Good Manufacturing Practices set forth by the FDA (cGMPs, 21 CFR 111/117 or equivalent);
- Products do not contain contaminants that may pose a human health or regulatory concern;
- Products contain the ingredients claimed on the product label.
“NSF is pleased Amazon is making sure the good players in our industry are rewarded and the bad players don’t have an avenue to sell,” said Trosin.
“Amazon’s global reach means their new dietary supplement policy update has the rare opportunity to impact human health and wellbeing on a massive scale,” he added. “We’re pleased NSF has been named an approved testing and certification solution for sellers who are seeking to comply with Amazon’s Dietary Supplement Policy.”
What impact Amazon’s policies will have on overall quality remains to be seen. Some are skeptical.
“I don’t think you can outsource quality, and it seems to me to be what amazon is trying to do,” said Monheit. “The current proposal puts document review on quality into a few hands, compromises existing vendor relationships, and simply does not solve the problem while encumbering the system with both time and cost. And it doesn’t solve parts of the problem like counterfeit products. I am not impressed.”
Getting The Basics Right
Meanwhile, FDA inspections of manufacturing facilities have continued to point to the same 483 observations, which are fundamentals of GMPs.
“The most often cited FDA observations are failure to set and appropriately test for quality specifications,” noted Chang. “Industry must ensure their quality systems are meeting the mandatory requirements in 21 CFR Part 111 and 21 CFR Part 117. Dietary supplement products are not approved by the FDA before they go to market, so it is critically important that manufacturers understand and follow these requirements.”
Monheit noted that FDA makes results of its inspections public, and at this point, there’s no excuse for failure. “Demand better of the CMOs, and go to CMOs who have a good history with FDA. Get your supply chains in order and get a good lab working with you,” he said.
Industry would also be well advised to bring in an accredited third party like NSF, said Trosin. “From supply chain to product going out the door, improvement looks like documenting behavior, measuring progress, investing in training and education, and living a culture of quality. In more cases than not, an unbiased third-party of experts can see both problems and their solutions with fresh eyes.”
Chang also noted that “Many consumers and healthcare practitioners value oversight from an independent third-party organization not associated with the manufacturer, and with the necessary expertise to assess quality, like USP.”
Because dietary supplements are regulated as a category of foods and therefore do not require FDA’s approval before going to market, “there can be a significant quality disparity in the supplement market,” Chang said. “It is in a brand’s best interest to pursue third-party verification to demonstrate commitment to quality and the real quality of their products — both to healthcare practitioners who will recommend dietary supplements, and to consumers who are making purchasing decisions themselves.”
USP’s Dietary Supplement Verification Program (DSVP) involves a three-step process, including a manufacturing facility audit, a quality document audit, and product testing to confirm the quality of a product. Products that meet the program’s testing and evaluation criteria are awarded the distinctive USP Verified Mark, which can be used on product-labeling, packaging and promotional materials to help differentiate a product in the marketplace.
The USP Verified Mark signals to healthcare practitioners and consumers that a product is of trusted quality, said Chang.
“A USP-led survey of nearly 300 licensed healthcare practitioners, including dietitians, nutritionists, physicians, pharmacists, and nurse practitioners, found that the USP Verified Mark was the #1 recommended seal/mark by healthcare practitioners to their patients,” Chang said.
USP’s DSVP also helps brands expand into new locations by helping them meet retailer requirements for quality dietary supplements.
“USP Verification significantly reduces the possibility of product recall and provides brand representatives with a seal to point to when communicating the quality of their product,” Chang added.
What else can brands do to raise the bar for supplement quality?
“Supplement sustainability is an emerging but persistent trend that plays into a customer perception of supplement quality,” said Trosin.
“In addition to the manufacturing and product quality guidelines that all supplements should adhere to, developing products, packaging, and manufacturing best practices that support and promote sustainability can be the silver bullet that differentiates your product from competitors.”
Ultimately, third-party certification and standards highlight a business’ commitment to safety, quality, sustainability, and performance, said Trosin, while also demonstrating compliance and building consumer confidence.
“The value certification brings is almost incalculable, impacting everything from bottom line finances and mitigated legal costs to customer sentiment and brand reputation,” he said. “NSF strongly encourages brands and businesses to seek certification to third-party standards for their own reputational health and financial longevity.”
For Vitaquest, Lawson said third-party certification provides an independent assessment and confirmation that an effective quality system is in place.
“They are also important because they fill in the gaps of FDA inspections,” he noted. “FDA inspections only occur every couple of years in some instances, so third-party certifications help maintain continuous oversight and assurance of quality standards in the interim.”
About the Author: Sean Moloughney has been the editor of Nutraceuticals World since 2012. He can be reached at smoloughney@rodmanmedia.com.
