The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of risk assessments with regard to contamination by nitrosamines in APIs. It needs to be completed for one API at a time and complies with the applicable requirements for risk assessment in the field of nitrosamines as specified by the regulatory authorities.
As early as February 2020, the Active Pharmaceutical Ingredients Committee (APIC) published the first version of the report together with the guideline "Additional guidance on the risk assessment for presence of N-nitrosamines in APIs." While the first version of the guideline remained unchanged, the second version of the questionnaire shows some essential updates and changes....[APIC-ECA]