Sabinsa has announced that its Nelamangala biotechnology site in Bengaluru, India, has passed the United States' GMP audit. The company received the GMP compliance certificate from USP on 25 February 2019.
The certificate recognises that the site operates GMP quality systems that 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.
The biotechnology unit 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.
Majeed added: “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 programme 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.”
Quality assurance
The USP’s GMP audit programme 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 is pleased to recognise 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," he added.
Sabinsa, founded in 1988, is a manufacturer and supplier of herbal extracts, cosmeceuticals, probiotics, minerals, and speciality fine chemicals.
The company markets over 100 standardised botanical extracts, and employs more than 1,000 people worldwide in 11 manufacturing, R&D, sales, and distribution facilities.
Process development and product innovation form the focus of the ongoing R&D efforts in the company’s research facilities, located in India and the US.
Products, many of which are both Kosher and Halal, are extensively researched, patented, and supported by hundreds of published clinical studies.
Sabinsa’s botanical cultivation programme totals nearly 40,000 acres to ensure sustainable, fair trade materials are used in these ingredients.
