Guidance on nitrosamine impurities in medications.: H164-327/2024E-1-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.938524&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance on nitrosamine impurities in medications. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance on nitrosamine impurities in medications. (March 2024) |
| Format | Electronic |
| Electronic document | |
| Note(s) | 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. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, May 2024. ©2024 |
| Description | 1 online resource (iii, 56 pages) : illustrations (some colour) |
| ISBN | 9780660720524 |
| Catalogue number |
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| Departmental catalogue number | 240217 |
| Subject terms | Nitrosoamines -- Risk assessment -- Canada. Drugs -- Risk assessment -- Canada. Biologicals -- Risk assessment -- Canada. Radiopharmaceuticals -- Risk assessment -- Canada. Pharmaceutical policy -- Canada. |