Practical implication
Manufacturers must evaluate their products against the new thresholds and update their risk management plans (RMPs) and risk-based monitoring protocols if any exceed the limits.
The Therapeutic Goods Administration (TGA) updated its guidance on acceptable intake (AI) limits for nitrosamine impurities in medicines, introducing revised limits for various impurities and aligning TGA standards with international recommendations. Sponsors and manufacturers are required to assess their products against these new thresholds and ensure compliance by updating risk management plans (RMPs) and monitoring protocols accordingly.
What changed: The TGA has revised the acceptable intake limits for nitrosamine impurities to align with EMA guidelines. Affected sponsors and manufacturers must review their products to ensure they meet the new AI limits.
Why it matters: Failure to comply with the updated AI limits may result in non-compliance with safety regulations and could jeopardize product approvals and market access.
Practical implication: Manufacturers must evaluate their products against the new thresholds and update their risk management plans (RMPs) and risk-based monitoring protocols if any exceed the limits.
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Published from the Firecrawl policy change extraction pipeline.
