UPDATED - Health Canada - Q&A Document on Nitrosamine

Health Canada spell it out quite clear on its Q&A Document on Nitrosamine (Updated 15Dec20):

  • Q6: What are the responsibilities of API manufacturers, excipient manufacturers, drug
    product manufacturers, MAHs, and importers? To enable this robust risk assessment, information should be made available by API, excipient, and drug product manufacturers to the MAH.

  • Q8: Is it acceptable to rely solely on statements or declarations by manufacturers and
    suppliers in lieu of completing risk assessments? No. Statements and declarations provided by manufacturers and/or suppliers are not a substitute for an overall robust risk assessment by the MAH

  • Q9: Is it acceptable to skip the risk assessment step (Step 1) and proceed directly to
    confirmatory testing (Step 2)? No. The risk assessment step (Step 1) is necessary to identify possible root causes and thescope of nitrosamine impurities that have the potential to be formed, or otherwise introduced into the API or drug product.

This document was sent to all DIN, DEL, and MF Types I and IV holders. A copy of the latest version can be requested by contacting hc.bps.enquiries.sc@canada.ca

HC QnA Document on Nitrosamines - Update 2 (ver. 2020-12-15) (final).pdf (550.5 KB)

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Health Canada has updated their Guidance on nitrosamine impurities in
medications in May 2022.

For the latest see: