Health Canada last week published an updated Guidance *on Nitrosamine Impurities in Medicines.
Notable new or updated information includes the following:
Under General:
Considerations relating to the filing of certain applications when risks of nitrosamines have been identified.
Under Safety:
10 nitrosamines now included in list of established acceptable intake (AI) limits
applying the class-specific threshold of toxicological concern (TTC) of 18 ng/day for nitrosamines as a default limit when there’s no established AI
new guidance on AI limits for nitrosamines in drug products that fall within the scope of ICH’s S9 guideline or where the API is genotoxic
updated guidance on AI limits when multiple nitrosamines are found in an API or drug product.
Specifically AI for NDELA is being listed.
Under Quality:
potential root causes for presence of nitrosamines
details on control strategy options when there are nitrosamines
recommendations on testing a representative number of batches when a risk issue has been identified and the root cause is known.
guidance-nitrosamine-impurities-medications-eng (1) (1).pdf (756.6 KB)