Implementation of quality tools in the technological development of vaccines and biopharmaceuticals

Introduction:As technological product development advances, the robustness of acquired information increases, requiring greater rigor and formalization in quality tools.This ensures compliance with regulatory requirements, good pratices (GxP), and internal criteria.The complexity of pharmaceutical development demands a structured approach to quality management, integrating risk assessment strategies and ensuring consistency throughout all product lifecycle stages.Objectives: To implement a quality management system (QMS) in the technological development chain of Bio-Manguinhos, ensuring regulatory compliance, optimizing processes, promoting risk-based decision-making and fostering a strong quality culture that supports innovation. Methodology:A systematic literature review was conducted, followed by a comparative analysis of the correlation between development phases and regulatory requirements.This analysis guided the creation of a structured, tactical-level quality system document (program), integrating risk management into each stage.The framework and quality tools were tailored to the maturity of each phase, ensuring knowledge acquisition and risk assessment alignment. Results:The QMS required the development of supporting documentation aligned with roles defined in the Organization's Manual.The program enabled greater flexibility for experimentation while ensuring compliance, leading to well-documented, properly registered pharmaceutical products.This structured approach improved process control, traceability, and regulatory alignment.It also enhanced project execution, reducing inefficiencies, rework, and approval delays.A key outcome was the successful implementation of an mRNA platform for vaccine development, demonstrating the program's ability to support innovation while meeting regulatory standards. Conclusion:Implementing a structured QMS at Bio-Manguinhos optimized technological development processes, strengthened the quality culture, and improved regulatory compliance.The integration of risk-based methodologies and continuous staff training reduced uncertainties and increased efficiency, ensuring the delivery of safe, high-quality pharmaceutical products that meet national and international regulatory expectations.