“With respect to dietary supplements, the publication of the standards is imminent: Within a matter of weeks,” Michael Finamore, CEO of Gemini Pharmaceuticals Inc. and inaugural president of the GRMA Governance Board, told us at the recent SupplySide West show in Las Vegas.
“That’s the culmination of a two to three year process developing the standards and have the ANSI [American National Standards Institute] process work its way through.
GRMA 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. The alliance currently includes over 30 major retailers in the grocery, drug, mass merchandiser and club store channels, representing US-based and international operations.
Manufacturers of dietary supplements must comply with current Good Manufacturing Practices (cGMPs), while retailers may also have a number of additional requirements for manufacturers, which can lead to variety of standards. The GRMA aims to “tie” all these additional auditing requirements into one industry audit for retailers to audit and inspect supplier and manufacturer vendors.
These standards should reduce the number and associated costs of audits, while strengthening safety, quality and trust throughout the supply chain.
“The pilot audits are being done, which are really structured to give the auditors an opportunity to take the training out into the field and make sure their auditing is being done to the standards of the GRMA scheme, ANSI 455. Additionally, those auditors are themselves being audited by ANSI to ensure they are trained.
“I was proud to have Gemini Pharmaceuticals be the first company to have the pilot audit. At the audit was UL – the auditing body chosen for that – ANSI representatives, and some retailers as well.
“The pilot audit was very interesting in that we learned how the changes to the GRMA audit scheme are going to impact manufacturing but also how the architecture of GRMA is set-up with respect to different systems, the auditsphere (which is how the audits will be reported), and how the auditor training itself has to be tweaked in order to get the most value for the retailers, customers, and members.
Finamore said that the industry response has been very strong. GRMA – by using an ANSI standard – really is establishing a new threshold, and raising the boats of quality for everyone involved. “Everyone is very interested to hear about it, especially once they understand how far in the process we’ve come,” he said.
“We have three initial certifying bodies as first movers who are trained to those standards, and those folks will soon be offering that.”
The GRMA is an audit standard for operations, he said, but it has the architecture to expand throughout the entire part of the manufacturing process, including the supply chain, finished product testing, and others.
The creation of an ANSI standard and having the audit scheme along with that has “raised the bar”, said Finamore.
“The idea is to enforce the ‘c’ in cGMP, and we believe the GRMA represents the finest opportunity to do that.”
The GRMA Governance Board includes members from across industry, including Gemini Pharmaceuticals, Costco, Wegmans Food Markets, HEB Grocery Company, United Exchange Corp, and First Quality.