ANN ARBOR, Mich. — The Global Retailer and Manufacturer Alliance plans to publish the first ANSI-approved GMP standard for dietary supplements this spring, the association announced Wednesday, and is hiring an administrative manager and launching a website to encourage participation in the ANSI standards development process.
“We’ve had tremendous participation from store brand retailers, manufacturers, trade associations and certification bodies,” stated Casey Coy, interim manager of the GRMA. “Our new website will make it easier for individual stakeholders to participate in GRMA activities and the ANSI standard development process.”
"As part of the ANSI standard development process, we now expect the GMP standard for dietary supplements to be published for public comment in spring 2017”The GRMA’s new ANSI-approved standard for GMP audits will be unique — including audit requirements, audit processes and requirements for certification bodies. By combining regulatory GMP requirements and various retailer requirements, the standard will help ensure consistency and proper training of auditors, reduce the number of audits and financial costs associated with multiple audits, and strengthen safety, quality and trust throughout the supply chain.
Major retailers, manufacturers, trade associations and certification bodies began working together as the GRMA in 2014 — using the ANSI standard development process to develop a consensus-based American National Standard for GMPs in the dietary supplement industry. The GRMA is also developing ANSI standards to address other aspects of the supply chain, including ingredients/raw materials, warehouse and distribution, and packaging and labeling.
Beyond dietary supplements, the GRMA is working to develop additional standards for other product categories, including cosmetics/personal care products, over-the-counter drugs and medical devices. All third-party certifiers will be able to certify to the new ANSI-approved standards.
“As part of the ANSI standard development process, we now expect the GMP standard for dietary supplements to be published for public comment in spring 2017,” Coy said. “The GMP standards for cosmetics and personal care products, over-the-counter drugs and medical devices are on track to be published later in 2017.”
The ANSI standard development process requires a consensus from a balanced group of stakeholders (including industry, public health regulators and users) who participate in a joint committee process. This consensus-building process is designed for openness and transparency — requiring open discussion, input from stakeholders (including a commenting and voting process) and an appeal process. Developing an ANSI standard is a rigorous process that generally takes from 18 months to 36 months.
The GRMA initiative currently includes more than 20 major retailers in the grocery, drug, mass merchandiser and club store channels, representing U.S.-based and international operations. More than 100 representatives from store brand retailers, manufacturers, trade associations, certification bodies, academia, government and industry consultants are participating in GRMA activities. The GRMA Governance Board includes members from retailers (Costco, H-E-B, Walgreens and Wegmans) and manufacturers (First Quality Products, Perrigo, UEC and Vi-Jon).