Lallemand Health Solutions is proud to announce that both of its 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,” comments 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”, explains 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. “
Lallemand Inc. is a privately owned Canadian company specializing in the development, production and marketing of yeast and bacteria, as well as other ingredients linked to these microorganisms or their markets.
Lallemand Health Solutions
Backed by a rich history and 80 years of expertise in probiotic research and development, Lallemand Health Solutions offers a full line of ready-to-market probiotic formulas and helps its partners to design their own custom & complex formulations using Harmonium, Lafti® or Rosell® Probiotic strains together with our proprietary protective technologies. Because, from the lab to the shelf, LHS controls the overall manufacturing process of its products, the company can ensure customers are receiving the highest quality standard of probiotic formulation. Cooperation spells success: we provide our partners with the full support they need to develop, register, and market their products in their own market, making Lallemand Health Solutions a complete probiotic solutions provider.
Lallemand Health Solutions covers more than 60 countries across five continents and is ready to service your probiotic needs.