09.01.17
Both of Lallemand Health Solutions Canadian probiotic production plants— in Montreal and Mirabel—successfully passed the United States Pharmacopeia (USP) Quality Systems Good Manufacturing Practice (GMP) audit. They thus have become the first probiotic production facilities to receive this quality certificate.
“Such achievement illustrates our long-standing commitment to quality and demonstrates the level of our quality systems. For our customers, this helps provide them with assurance in the quality of our probiotic production operation. It also represents a stepping stone for those willing to get their finished product compliant with the USP verified program,” commented Francine Mondou, president of Lallemand Health Solutions.
“USP is the most authoritative source for dietary supplement GMP audits. USP’s GMP audit program serves dietary supplement and dietary ingredient manufacturers. It provides assurance that dietary supplement manufacturers not only meet FDA cGMPs, but exceed them, as it is the only program that requires manufacturers to comply with both FDA and USP GMPs. USP GMPs include requirements of particular interest to retailers such as recall procedures, expiration dating supported by stability data for instance,” explained John Atwater, senior director of verification services for USP. “This is the first time a probiotic production facility’s GMP quality systems have been verified by USP, and this can facilitate the task for the companies wanting to participate in USP verified program for their finished products, as more and more dietary supplement companies are interested in doing so,”he added.
Solange Henoud, regulatory affairs director at Lallemand Health Solutions further commented: “In practice, this means that USP’s audit found that Lallemand’s quality system provided sufficient assurance that its two Canadian manufacturing sites met applicable FDA and USP GMP audit requirements. With the reputation of USP, we are confident that this will facilitate recognition by regulatory authorities beyond borders.”
“Such achievement illustrates our long-standing commitment to quality and demonstrates the level of our quality systems. For our customers, this helps provide them with assurance in the quality of our probiotic production operation. It also represents a stepping stone for those willing to get their finished product compliant with the USP verified program,” commented Francine Mondou, president of Lallemand Health Solutions.
“USP is the most authoritative source for dietary supplement GMP audits. USP’s GMP audit program serves dietary supplement and dietary ingredient manufacturers. It provides assurance that dietary supplement manufacturers not only meet FDA cGMPs, but exceed them, as it is the only program that requires manufacturers to comply with both FDA and USP GMPs. USP GMPs include requirements of particular interest to retailers such as recall procedures, expiration dating supported by stability data for instance,” explained John Atwater, senior director of verification services for USP. “This is the first time a probiotic production facility’s GMP quality systems have been verified by USP, and this can facilitate the task for the companies wanting to participate in USP verified program for their finished products, as more and more dietary supplement companies are interested in doing so,”he added.
Solange Henoud, regulatory affairs director at Lallemand Health Solutions further commented: “In practice, this means that USP’s audit found that Lallemand’s quality system provided sufficient assurance that its two Canadian manufacturing sites met applicable FDA and USP GMP audit requirements. With the reputation of USP, we are confident that this will facilitate recognition by regulatory authorities beyond borders.”
