I want to share the newly published guidance from ANVISA on the Control of Nitrosamines in APIs and Medicines. Any interest from our community members to organize a Q&A session with some of the Brazil members to introduce the guide details?
I personally find interesting these on the guidance:
- 3 phase approach (Risk Assessment, Confirmatory testing and Process changes)
- Specific expectations regarding risk assessment (334-344)
- Section dedicated to Applicability of ‘Purge’ concept in line with ICH M7 option 4 (356-359)
- Referenced used for “Purge” factor calculations @AndyTeasdale @MichaelBurns
- API supplier testing of Nitrosamine DOES NOT exempt the need for risk assessment in the finished product (417-421)
- Guideline on number of batched to be tested based upon risk assessment (424)
- Use of limits based on the concept of TTC is not applicable
- Limits cited in the guidance for NDMA / NDEA / EIPNA / DIPNA / NMBA / MeNP / NDBA / NMPA
- Some limits were established based on (Q)SAR and consider ‘interim limits’
- Two case scenarios when more than one nitrosamine is present (493)
- Approach to derive limits to new nitrosamines, reference to " Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines" –Link– @David
- Concept of LTL approach @jbercu
(1)Guia_50_Nitrosaminas_rev_final_para publicação (1).pdf (1.0 MB)
