In the rapidly-changing world of retail, one challenge has been consistent: the complexity of compliance. Prior to the introduction of the Global Retailer and Manufacturer Alliance (GRMA) NSF/ANSI 455 standards, safety and quality criteria varied across retailers, creating an ungainly (and for some smaller manufacturers, impossible) web of expectations and requirements in assessing Good Manufacturing Practices (GMPs) for entire aisles of consumer products.
The pressure on retailers to ensure regulatory compliance and reduce risk to the consumer is constant. And as in every industry, retailers will seek to focus the burden of that risk, in this case onto the shoulders of their suppliers and manufacturers. Forward-thinking manufacturers will turn that risk into brand equity by illustrating their ability to meet those regulatory requirements and provide independent assurance of GMPs.
Evolution towards new GRMA standards
In the pre-GRMA environment, manufacturers were driven to focus on the differences between retailer requirements, rather than the commonalities. The GRMA strove to create a set of standards to flip that script, by recognising the commonalities in manufacturer requirements, and then harmonising the outlying differences. This included addressing the differences presented by distribution channels as varied as mass merchandisers, club/membership warehouses, chain and independent drug stores and grocery stores.
To harmonise these criteria, expectations and requirements for GMP audits, leaders from top retailers, manufacturers, industry regulation bodies, applicable trade groups and other interested parties formed the GRMA in July 2014. The mission was to create balanced, transparent, consensus-based GMP standards to strengthen safety, quality and consumer confidence. In the ensuing period, GRMA has created standards for three different industry sectors: dietary supplements, cosmetics/personal care items and over-the-counter (OTC) drugs sold in retail outlets.
Developing and certifying to harmonised GRMA standards allows industries to demonstrate compliance with a comprehensive list of certification requirements relevant and applicable to retailers, manufacturers and regulators. Combining the retailer, manufacturer and regulatory requirements into a single standard and auditing program for each industry sector also helps strengthen safety, quality and trust throughout the supply network.
The GRMA standards initially defined a consistent approach for auditing, and later for product testing and claim substantiation for dietary supplements, cosmetics and personal care products. The standards encompass relevant regulations, retailer requirements and industry best practices. The applicable regulations serve as a baseline for each standard including:
- Dietary supplements – Current Good Manufacturing Practices (GMPs) for dietary supplements as referenced in Title 21 of the Code of Federal Regulations (CFR) Parts 111 and 117, which are a component and requirement of the only American National Standard for dietary supplements, NSF/ANSI 173
- Cosmetics/personal care products – ISO 22716, Good Manufacturing Practices (GMP) for cosmetics and U.S. FDA cosmetic GMP guidance for OTC drug products (21 CFR Part 210) and finished pharmaceuticals (21 CFR Part 211)
For manufacturers and suppliers, this harmonisation goes a long way toward alleviating 'audit fatigue.' Uniform standards provide a clear, consistent roadmap for meeting the requirements of multiple retailers with, at minimum, one annual audit as part of the certification process.
All for one and one for all
Pre-GRMA, retailers had customised audits, a time-consuming and costly structure for both the retailer and manufacturer. Some dietary ingredient and supplement manufacturers report as many as 300 audit days in a year, and every day devoted to an audit is a day that impacts peak productivity. If this structure posed a significant cost challenge for the largest of industry manufacturers, it’s easy to see how it may often have been an insurmountable obstacle for small to medium-sized entities seeking a foothold in the largest retail networks.
The GRMA standards should significantly reduce that burden for dietary ingredient and dietary supplement manufacturers, by standardising certification audit requirements for multiple retailers under a single, comprehensive set of standards. The GRMA GMP audit of one manufacturer can be shared with multiple retailers in place of multiple retailer audits. Ultimately this will elevate quality and reduce costs for everyone.
Challenges for consideration
The new GRMA standards bring a few challenges of their own. For example, dietary supplement ingredient and supplements manufacturers currently being evaluated for compliance to 21 CFR 111 should know that that is no longer sufficient under GRMA certification. There are Food Safety Modernization Act (FSMA) and 21 CFR 117 requirements that go beyond 21 CFR 111, covering additional impactful regulatory requirements for GMP, allergen controls, hazard analysis and risk-based preventive control elements.
The challenges are not limited to manufacturers. To perform GRMA audits, certifying bodies must obtain accreditation for GRMA audits by demonstrating understanding of the standard criteria and proficiency in conducting the audits. The good news is the organisations accrediting the certifying bodies have made strides to help ensure that certifying bodies are prepared for this new environment. In February 2020, the ANSI National Accreditation Board (a wholly owned subsidiary of ANSI) launched a new pilot accreditation program for the GRMA scheme. Per the GRMA website, the scheme focuses on multiple non-food product categories, including dietary supplements, OTC drugs, cosmetics and personal care products.[i] Certifying bodies are now training auditors and demonstrating auditing competency through gap or pre-assessment audits during the pre-established grace period in which unaccredited audits are permitted by GRMA. NSF International has completed training for its global base of auditors and is excited to begin offering these audits.
The first step for dietary ingredient and supplements manufacturers in preparing to meet the GRMA standard requirements is obtaining a copy of the standard, as well as the auditor requirements guideline. Using those to evaluate their manufacturing practices may illuminate gaps prior to an audit. For manufacturers seeking stronger assurance, gap assessments (sometimes called pre-assessments) by qualified auditing organisations offer concrete, actionable data that can be used to create a timeline for addressing non-conformances in advance of the eventual GRMA audit.
References
[i] https://grmalliance.org/press-releases/ansi-national-accreditation-board-anab-launches-accreditation-program-for-global-retail-and-manufacturer-alliance-certification/
