On September 4th, the FDA published Revision 2 of the “Guidance for Industry – Control of Nitrosamine Impurities in Human Drugs.” This new version introduces significant updates that manufacturers and stakeholders in the pharmaceutical industry should be aware of.
Among the key changes, the revision includes a new section focused on Nitrosamine Drug Substance-Related Impurities (NDSRIs). This section highlights:
- Potential Root Causes: An exploration of how NDSRIs may form during drug production, such as certain chemical reactions or contamination from raw materials.
- Mitigation Strategies: Recommendations for actions that manufacturers can take to prevent or minimize the presence of these impurities in drug substances and products.
The updated guidance also classifies nitrosamine impurities into two main types:
- Small-Molecule Nitrosamine Impurities: These impurities do not share structural similarity to the active pharmaceutical ingredient (API) and may be found across a range of drug products.
- NDSRIs: These impurities have a structural similarity to the API and are generally unique to each API.
This revision aims to help manufacturers better understand and control the risk of nitrosamine impurities, ensuring the continued safety and efficacy of human drugs.
Stay informed and compliant! For more details, read the full FDA guidance here: FDA Guidance on Control of Nitrosamine Impurities.
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