Regulatory modernization and lifecycle management of analytical methods in the brazilian pharmaceutical industry

Introduction:The Brazilian pharmaceutical industry is undergoing regulatory modernization through the update of RDC 166/2017 to align with ICH guidelines.The incorporation of the updated ICH Q2(R2) for method validation and ICH Q14 for lifecycle management into Brazilian regulation is expected to enhance efficiency, and flexibility of pharmaceutical processes, fostering innovation and quality.Objectives: This study emphasizes the need to update RDC 166/2017 to incorporate lifecycle management and new analytical method approaches, as well as the associated challenges and benefits for the Brazilian pharmaceutical industry. Methodology:A comprehensive review of technical and regulatory literature, including ICH, USP, and relevant scientific articles on lifecycle management and analytical method validation, focusing on their impact on RDC 166/2017.Results: A revision of RDC 166/2017 should incorporate a lifecycle-based approach that promotes continuous data collection and analysis, enabling a proactive and scientifically sound way for developing, validating, and managing analytical methods.This includes strategies such as quality risk management and design space determination.Accordingly, an analytical control strategy must be implemented to ensure that the method's performance meets the analytical target profile requirements.In this context, pharmaceutical companies must adopt new strategies to meet updated regulations.Key measure includes continuous professional training, revision of standard operating procedures to integrate the lifecycle approach, and investment in advanced technologies such as statistical software and data management systems to enhance analytical validation. Conclusion:The update of RDC 166/2017 is expected to enhance validation processes, optimize resources, and accelerate the development of innovative products, promoting regulatory flexibility by ensuring quality through a mechanistic understanding of the processes.However, a successful transition will require the development and implementation of continuous monitoring methods within the industries.