Sabinsa Achieves USP GMP Audited Status for Three Additional Sites
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 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 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.
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.