USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Canada HC Guidance: Nitrosamine Impurities in Medications
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Health Canada: Guidance on Nitrosamine Impurities in Medications
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023