The Sami-Sabinsa Group’s Nelamangala biotechnology site in Bengaluru, India has been audited by the United States Pharmacopeia (USP) and received a GMP compliance certificate on February 25, 2019. The certificate recognizes that the site operates GMP quality systems which meet the requirements set forth in 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food, and USP-NF General Chapter Manufacturing Practices for Dietary Supplements for Dietary Ingredient Manufacturing.
This site produces Sabinsa’s probiotics, enzyme blends as well as Supercritical Fluid extraction of various botanicals.
“All of our facilities have undergone many inspections and certifications through the years and will continue to do so” said Sabinsa founder Dr. Muhammed Majeed. “While we always encourage customers to visit us in India and see our five manufacturing facilities for themselves, we realize that’s not possible for everyone. Participating in the USP GMP audit program is another way we can assure customers of our steadfast commitment to producing quality ingredients. Our other facilities are scheduled for USP auditing in the near future.”
“USP is pleased to recognize Sabinsa’s successful completion of the USP Quality Systems GMP Audit Program for this site,” said John Atwater, Senior Director of USP Verification Services. This demonstrates Sabinsa’s commitment to quality and to operating GMP quality systems for the manufacture of dietary ingredients in compliance with officially recognized requirements.
USP’s GMP audit program helps dietary ingredient manufacturers ensure compliance with GMP requirements and reduce risk while also providing them with a way to differentiate and qualify their manufacturing facilities and operations for their customers, finished product manufacturers, in an increasingly competitive global market. USP’s GMP audit program includes annual audits of a manufacturing site’s quality systems compliance with GMPs. Having received recognition from USP, Sabinsa earned a USP Quality Systems GMP Audited Certificate, and was added to USP’s website www.usp.org/verification-services/gmp-audit-program, a resource for finished product manufacturers to identify ingredient manufacturers who have earned the right to use the USP Audited Good Manufacturing Practices Mark.
About USP’s Quality Systems GMP Audit Programs
USP’s Quality Systems GMP Audit Program for Dietary Ingredients offers rigorous third-party auditing services to help companies achieve quality management in the manufacture of their dietary ingredients for use in the production of finished dietary supplements. Companies whose manufacturing operations meet USP’s comprehensive and stringent audit requirements are awarded a USP Quality Systems GMP Audited Certificate and use of the USP Audited Good Manufacturing Practices Mark. The Mark can be used in promotional materials and on business-to-business websites. USP has a longstanding history of commitment to quality in dietary supplements and is an authoritative source for GMP auditing services. USP’s standards for dietary supplement manufacturing practices predate the existence of DSHEA and FDA GMP requirements. USP standards are trusted around the world to help ensure quality in medicines, dietary supplements and foods.
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.