Malcolm Ross
Consultant
Malcolm Ross is a pharmacist and medicinal chemist working in the pharmaceutical industry for over 30 years. Worked in the generic industry for over 30 years in Israel, USA and Poland.
From 2016, based in Switzerland, has acted as a consultant and trainer for many companies in Europe and Asia and has been an external employee of Novartis in various roles including QA, Technical services and as a member of the Nitrosamine task force.
DAY 2: December 5th, 2024
SESSION: Nitrites: The elephant in the room
◆ The role of nitrites in excipients in the formation of NDSRIs in drug products.
◆ The reasons behind the presence of nitrites in excipients and some reasons for the very high variability of reported levels.
◆ Processing air as a source of nitrite and nitrosation.
DAY 2: December 2nd, 2022
SESSION: Pharmaceutical operations as generators of Nitrosamines – prevention or cure?
◆ Formation of nitrosamines does not only occur during manufacture of drug substances but can occur during manufacture of drug product.
◆ Different unit operations exhibit different levels of risk and mechanisms are still being elucidated.
◆ Prevention of formation during drug product production may be through control of processes, control of excipients or use of nitrosamine scavengers.
