ANSI-approved dietary supplement GMP standard, to be released in early 2017, will improve safety, quality and trust and reduce auditing costs
ANN ARBOR, Mich. – The Global Retailer and Manufacturer Alliance (GRMA) is nearing completion of an ANSI-approved, consensus-based American National Standard for Good Manufacturing Practices (GMPs) in the Dietary Supplement industry. The standard, the first to be released under the GRMA initiative, can be used as a companion to ANSI/NSF 173, the official American National Standard for dietary supplement products.
Global public health organization NSF International brought together leaders from major retailers and manufacturers in 2014 to form the Global Retailer and Manufacturer Alliance (GRMA).The group also includes trade associations, certification bodies, academia, government agencies and other stakeholders seeking to improve quality, safety and regulatory compliance to ultimately benefit the consumer.
Under NSF’s leadership, the GRMA is developing consensus-based GMP standards for dietary supplements, cosmetics/personal care products and over-the-counter (OTC) drugs by combining retailer and regulatory requirements into a single accredited GMP standard for each product category. The GRMA also plans to rely upon the American National Standards Institute (ANSI) approved GMP standard, ANSI/AAMI/ISO 13485, to create a consensus-based audit program for medical devices. Both the standards and the audit program are being developed utilizing input from manufacturers, retailers and public health members. The standards for cosmetics/personal care products and OTC drugs will be released later in 2017, as will a GMP medical devices audit program.
These GMP standards will reduce the number and associated costs of audits, while strengthening safety, quality and trust throughout the supply chain. With these standards, manufacturers can trust their suppliers, retailers can trust manufacturers, and the consumer can trust the product, all of which benefits the entire industry.
Developing an American National Standard requires an open process with consensus from a balanced group of stakeholders including industry, public health regulators and users who participate in a joint committee process. As a result, consumers can trust these standards knowing that they were not created by any one special interest or private group. This also sets the stage for industry-recognized standards that will be sustainable for years to come.
“It’s not easy to meet the ANSI Essential Requirements, but this effort assures that the standards define expectations of all stakeholders,” said Joe Bhatia, President of ANSI. “Lesser documents rushed to market may not hold up to requirements demanded by industry. The ANSI process is a proven benchmark providing confidence and managing risk, and we are proud to continue to work with NSF International as it leads development of crucial standards for health and safety.”
The GRMA is an industry-changing initiative and will include universally supported objectives that retailers and manufacturers have been seeking. A recent GRMA meeting convened at NSF International in August had the largest attendance to date, with over 100 representatives from store brand retailers, manufacturers, trade associations, certification bodies, academia, government and industry consultants.
The GRMA Governance Board includes members from retailers (Costco, HEB, Walgreens and Wegmans) and manufacturers (First Quality Products, Perrigo, United Exchange Corp (UEC) and Vi-Jon) to provide oversight for the entire GRMA membership. The GRMA initiative currently includes over 20 major retailers in the grocery, drug, mass merchandiser and club store channels, representing U.S.-based and international operations.
“The GRMA has filled a long-time unmet need for independent, consensus-based standards for retailers and manufacturers, and we are thrilled to be a part of the solution,” said Betsy Crater, Wegmans Non-Foods QA Manager.
“Working together for a common goal which benefits all the parties certainly is worth the effort,” said Alain Turenne, Walgreens Divisional Vice President of CSR and Product Integrity.
“We encourage all interested parties, retailers, manufacturers, trade associations, certification bodies, government and academia to join this industry initiative,” said Casey Coy, NSF International’s Program Manager for the GRMA and the Cosmetics/Personal Care program. “The GRMA standards will represent improved audit uniformity, competence and quality that will be independent, fair, robust and trusted, providing a benchmark of transparency for vendors, retailers, regulators and consumers.”
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About GRMA: The Global Retailer and Manufacturer Alliance (GRMAlliance.org) is a store brand industry initiative driven by retailers, manufacturers, trade associations, certification bodies, academia, government agencies and other stakeholders seeking to improve quality, safety and regulatory compliance to ultimately benefit the customer.