Brasília – Anvisa released a new guideline establishing updated parameters for the identification, reporting and qualification of impurities and degradation products in pharmaceutical formulations. The document provides manufacturers with harmonized technical criteria to evaluate potential risks associated with chemical impurities, including thresholds for toxicological assessment and recommended analytical approaches. According to the agency, the guideline aims to strengthen product quality, enhance regulatory predictability and support industry compliance with international best practices.

The publication is part of Anvisa’s broader effort to modernize regulatory frameworks related to pharmaceutical quality and aligns with global standards adopted by agencies participating in the International Council for Harmonisation (ICH). The agency emphasized that the new guideline will assist companies in designing more robust quality systems and in ensuring the safety of medicines throughout their lifecycle.

Source: Anvisa

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