Health Canada updates Acceptable Intake limits for Nitrosamine impurities

Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

Health Canada has updated its list of established Acceptable Intake (AI) limits for nitrosamine impurities (Appendix 1), now available online. The update includes the addition of N-nitroso-dabigatran etexilate imide as a new impurity with a corresponding AI limit, along with revised limits for seven existing nitrosamines, including N-nitroso-folic acid, N-nitroso-vancomycin, and N-nitroso-mglumine – the latter significantly reduced from 1,500 ng/day to 100 ng/day. The updated list can be filtered by date to identify recent changes. Stakeholders are encouraged to consult the latest guidance on nitrosamine impurities in medications to ensure ongoing compliance.

For more information, reach out to us.

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

Health Canada updates Acceptable Intake limits for Nitrosamine impurities

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