Sami-Sabsina’s biotech facility achieves USP GMP audited status

The Nelamangala biotechnology site of Sami-Sabinsa Group in Bengaluru received a GMP compliance certificate after it was audited by the United States Pharmacopeia (USP)


Bengaluru: 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 25th February, 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 <2750> 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 Sami-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, a resource for finished product manufacturers to identify ingredient manufacturers who have earned the right to use the USP Audited Good Manufacturing Practices Mark.