00000nam 2200000zi 4500 9.938524 CaOODSP 20250819080451 m o d f cr mn||||||||| 240212e202405 onca ob f000 0 eng d 9780660720524 CaOODSP eng rda CaOODSP n-cn--- H164-327/2024E-1-PDF Guidance on nitrosamine impurities in medications. Ottawa, ON : Health Canada = Santé Canada, May 2024. ©2024 1 online resource (iii, 56 pages) : illustrations (some colour) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur les impuretés de nitrosamine dans les médicaments. "Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological and radiopharmaceutical products." "Date adopted: 2024-05-31." "Effective date: 2024-05-31." "Pub.: 240217"--Verso of cover. Includes bibliographical references. "This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to change as new information becomes available and if further guidance is needed for applicants and market authorization holders (MAHs). A questions-and-answers (Q&A) document on nitrosamines was issued to MAHs on November 26, 2019. This document has undergone a number of revisions and has been further updated as a guidance document and to provide additional details to active pharmaceutical ingredient (API) manufacturers, drug product manufacturers, MAHs and importers of APIs and drug products. In this guidance document, changes from the previous version are identified with the descriptors "new" or "updated" (as applicable). Information on a similar theme is grouped together under general headings (for example, General, Safety and Quality). …"--Background, page 1. Nitrosoamines Risk assessment Canada. Drugs Risk assessment Canada. Biologicals Risk assessment Canada. Radiopharmaceuticals Risk assessment Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Lignes directrices sur les impuretés de nitrosamine dans les médicaments. (CaOODSP)9.938526 Guidance on nitrosamine impurities in medications. (August 2025) (CaOODSP)9.948416 Guidance on nitrosamine impurities in medications. (March 2024) (CaOODSP)9.933796 PDF 1.16 MB https://publications.gc.ca/collections/collection_2024/sc-hc/H164-327-2024-eng-1.pdf 240217