Proposal for implementing continuous process verification in medicines developed by Quality by Design using the 5W2H tool
Vigil Sanit Debate, Rio de Janeiro, 2025, v.13: e02463 | Published on: 04/11/2025
DOI:
https://doi.org/10.22239/2317-269X.02463Keywords:
Quality by Design, Critical Quality Attributes, Risk Analysis, Continued Process Verification, 5W2HAbstract
Introduction: The inclusion of the Brazilian Health Regulatory Agency (Anvisa) in the International Coalition of Medicines Regulatory Authorities introduced the concept of the product lifecycle in drug development. In this context, Continued Process Verification (CPV) ensures continuous improvement and control of batch variability. However, there is a lack of details regarding CPV implementation in both national legislation and scientific literature. Objective: This study aimed to explore the theoretical aspects of CPV and outline the activities required for its implementation. Method: The research was conducted through a review of scientific articles and national and international regulatory guidelines. An action plan was developed using the 5W2H tool for CPV implementation. Results: Anvisa adopted the product lifecycle concept, with the Quality by Design (QbD) approach being recommended. QbD includes defining the quality target product profile and using experimental design to understand the relationships between formulation and process variables in the critical quality attributes. Risk management is essential in QbD and also plays a key role in process validation. CPV monitors process performance, detecting and correcting deviations to ensure product consistency. Tools such as statistical process control ensure controlled variability and continuous quality in production. Based on the information gathered, the 5W2H tool was applied to create an action plan for CPV implementation. Conclusions: This study provided a theoretical and practical foundation for CPV implementation, helping pharmaceutical companies adopt better practices in lifecycle management.
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Author Biographies
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Rosilene dos Santos Barros, Wasser Farma Ltda., Rio de Janeiro, RJ, Brasil
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Livia Deris Prado, Laboratório de Desenvolvimento e Validação Analítica, Instituto de Tecnologia em Fármacos, Farmanguinhos, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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