Brazilian requirements for stability indicating methods
2017
Moraes do Carmo, Ana Cerúlia | Pereira, Raphael Sanches | Gratieri, Tais
Stability studies guarantees that quality attributes will be maintained during a period under the influence of a variety of environmental factors, consequently maintaining drug product efficacy and safety. In this context, stability indicating analytical methods (SIAM) appears as a regulatory requirement to detect common observed impurities and those likely to appear during product shelf-life due to degradation. U.S. Food and Drug Administration (U.S. FDA), The International Council on Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH), World Health Organization (WHO), European Medicine Agency (EMA) have been discussing SIAM concepts and applications, as well as other scientific organisms. Brazilian Health Regulatory Agency (Anvisa) approached SIAM concept through regulations and guidelines in 2015. Hereupon this note intends to expose Brazilian requirements for drug products registration related to SIAM by establishing a comparison to international scenario.
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