Hello ,
Thankyou Naiffer for introducing me to the Nitrosamine Exchange community.
Am Dr Archana Bahuguna, a Regulatory Compliance Specialist having over 20 years experience in Pharmaceutical Industry leading drug substance, drug product CMC activities involving successful development programmes, Tech Transfers, Regulatory Inspections, Registration & commercialisation.
Have been involved in interactions with Inspectorates & Agencies across the globe with respect to Nitrosamine Impurities from the Regulatory Compliance perspective with the aim of integrating Science with appropriate Risk assessments to mitigate the Risks associated with Nitrosamines thereby preventing Product Recalls impacting drug shortages across Global Pharma supply chains.
Glad to be a part of this community and I look forward to more learnings & knowledge sharing on this forum.
Enclosed are a few links on Risk Assessment aspects of Nitrosamines: