What you should know about the GRMA standards

In part one of this two-article series (http://tinyurl.com/pnf2ko4), I discussed how the Global Retailer and Manufacturer Alliance (GRMA) is working to create consensus-based Good Manufacturing Practice (GMP) standards to provide a clear, consistent “roadmap” for meeting multiple retailer requirements with one certification. This article provides more detailed information about the standards and why they’re important.

The GRMA standards

The GRMA is developing four American National Standards Institute (ANSI) standards that will initially define a consistent approach for auditing — and later, for product testing and claim substantiation. The standards encompass both relevant regulations and additional uniform retailer requirements. We’re starting by incorporating applicable regulations as a baseline in each standard:

• Dietary supplements — Current GMPs in manufacturing, packaging, labeling and holding operations for dietary supplements (Title 21 of the Code of Federal Regulations [CFR], Parts 110 and 111), which are a component and requirement of the only American National Standard for dietary supplements, NSF/ANSI 173.
• Cosmetics/personal care products — ISO 22716 and FDA cosmetic GMP guidance encompassing GMPs for the production, control, storage and shipment of cosmetic products.
• Over the counter (OTC) drug products — GMPs in manufacturing, processing, packing or holding of drugs for finished pharmaceuticals (21 CFR, Parts 210 and 211). May include parts of the only standard for GMPs in pharmaceutical excipients, NSF/IPEC/ANSI 363.
• Medical devices — Quality system regulation/GMPs for medical devices (21 CFR, Part 820) and medical device reporting (21 CFR, Part 803).
   

Certification criteria

Certification criteria vary based on the specific product and include:

• Audits — required for initial certification and annually or biannually thereafter. Audits verify GMPS, including laboratory testing requirements, production and process controls, personnel qualifications, cleaning procedures, equipment maintenance and more.
• Product testing — may include ingredient, finished product and contaminant testing, including physical (properties, performance and integrity), microbiological and analytical testing.
• Label claim verification — may consist of toxicology, formulation and label reviews of ingredients and marketing or environmental claims such as organic, gluten-free, non-GMO, allergen-free, EPA Safer Choice, landfill-free, fragrance-free, compostable and non-toxic. Bottom line: Substantiation of all label claims is required to meet the expectations of the retailers.

Standard development process

NSF International is leading the ANSI standard development process, which ensures balanced input from a variety of stakeholders. We’ve formed a joint committee for each standard, representing users (manufacturers and certifiers), industry (retailers) and public health stakeholders such as regulatory agencies, academia and other interested parties. Task groups led by store brand manufacturers and retailers may also be formed to investigate particular issues of standards development.

Work on the dietary supplements standard began first, with the task group using the only American National Standard for dietary supplements, NSF/ANSI 173, as a template and then defining and incorporating retailer requirements into the GRMA standard.

Additionally, task groups are working to detail key elements of CFR Title 21, Parts 110 and 111, which cover GMPs for manufacturing, packaging, labeling or holding food or dietary supplements, respectively. The Federal Food, Drug, and Cosmetic Act states that these products must not be adulterated or mislabeled, but doesn’t specify how to achieve these guidelines. The GRMA standards will incorporate these specifications to make it easier for companies to demonstrate compliance.

Uniform standards benefit manufacturers, retailers and consumers

Certification to GRMA standards provides more than a third-party certification logo for consumer confidence. The documentation from independent certification — comprehensive audit reports, test results and label claim verification — provides manufacturers with the dossier they need to approach a retailer and peace of mind for regulatory compliance, product quality and consumer safety. These data also provide a means for retailers to verify label claims and protect their brands by reducing risk.

Retailers are responsible for ensuring all of their respective private label products meet applicable regulations, and the retailer, with its name is on the product, bears the risk for any non-conformances. For example, the recent New York Attorney General actions against several store brand herbal supplements may have damaged consumer confidence in all store brand supplements, but this situation could have been avoided, or quickly mitigated, if the appropriate documentation confirming all product claims had been on file.

Adherence to these new standards could lower the chance of a product recall, as the steps involved in achieving certification require documented processes and procedures that increase safety and quality and minimize risks.

The GRMA is open to all retailers, store brand manufacturers, relevant trade associations, regulatory and public health institutions, and certification bodies with a formal application approval. For more information or to participate in the development of the standards, please contact Casey Coy, GRMA Program Manager, at [email protected].