21 May 2019 | News
These state-of-the-art cGMP manufacturing units produce a range of Sabinsa’s ingredients
Three additional Sami-Sabinsa Group Manufacturing units have been audited by the United States Pharmacopeia (USP) and received GMP compliance certificates for the Kunigal unit and the Dobaspet unit, both in Bengaluru, India, and the Hyderabad unit in Telangana state, India. The company’s Nelamangala site in Bengaluru received a USP GMP certificate earlier this year. All four sites are certified Halal by The Islamic Food and Nutrition Council of America (IFANCA) and OK Kosher, with the Kunigal and Hyderabad units NSF-GMP certified as well.
The USP GMP certificate recognizes that the facilities operate 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.
These state-of-the-art cGMP manufacturing units produce a range of Sabinsa’s ingredients, from standardized botanical extracts to nutritional and specialty fine chemicals, for the food, beverage, dietary supplement, cosmeceutical and pharma industries.
The Kunigal and Hyderabad units are equipped to handle batch extractions, whereas the Dobaspet unit is a unique facility with continuous extractors made entirely of Stainless Steel (SS) 316 which can extract more than 40 tons of herbal raw material a day. The plant has scale and size to continuously extract oleoresin from herbal raw material.
“We’re pleased to have this assurance from USP reaffirm that our manufacturing facilities comply with U.S. cGMP requirements,” said Sami-Sabinsa founder Dr. Muhammed Majeed. “While we welcome and encourage customers to tour our facilities, USP audits can be reassuring for those not able to do so in person.”
“USP is pleased to recognize Sabinsa’s successful completion of the USP Quality Systems GMP Audit Program for this facility,” 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 facility’s quality systems compliance with GMPs. Having received recognition from USP, Sabinsa earned a USP Quality Systems GMP Audited Certificate, and also 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.