The Sami–Sabinsa Group now has a total of 14 staff members specifically trained in implementing the 21 CFR part 117 regulations, covering all of the company’s manufacturing facilities. Recently 13 staff members in India were trained per the Food Safety Preventive Control Alliance (FSPCA) by UL, the independent safety science organization, as Preventive Control Qualified Individuals (PCQI). There has been a trained PCQI officer in the Payson, Utah plant to comply with the Food Safety Modernization Act (FSMA) since July 2017.

“The changes required by FSMA, the most far-reaching overhaul of food regulation in the US since 1938’s Food, Drug and Cosmetics Act, make it absolutely necessary for many departments to work more closely together to implement the requirements,” said Dr. Muhammed Majeed, founder of Sabinsa. “For example, Purchase/Procurement teams, Phyto Identification teams, IT, and HR departments all have their roles carved out in implementing FSMA regulations because of the complex components. As an additional benefit to our continual quality improvement initiatives, this PCQI training helps Sabinsa to implement practices and procedures that minimizes the risk of contamination or other product safety issues and, thus, help to reduce the risk of regulatory and consumer actions in the first place.”

The FSPCA training UL provided to Sabinsa was geared specifically to the dietary supplements industry, rather than the more general food manufacturing industry. The training is wide-ranging, covering both best practices and specific preventive control measures such as allergen controls, hazard identification and preventive controls, and supply chain program management. In addition, attention is focused on microbiological testing, procedures for receiving incoming material, handling of finished formulations, and the potential biological hazards that can cause foodborne illness.

"Through our training and advisory services, UL is proud to have assisted Sabinsa to meet the requirements for PCQI through training," said Chris Aiyer, Senior Sales Executive, UL.

Sabinsa sells ingredients across the globe and follows the regulatory requirements in each country in which it does business. For meeting US-specific regulatory requirements, US FDA has inspected multiple Sami Labs facilities including the Nelamangala biotech plant and the Super Critical Fluid Extract (SCFE) facility under the FSVP (Foreign Supplier Verification Program). The Kunigal facility, which hosts the largest herbal extraction capabilities for the Sami-Sabinsa Group, underwent another routine US FDA inspection earlier this year.


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