Integrated Approach In Managing Continued Process Validation CPV APQR

Pharmaceutical and biopharmaceutical regulatory bodies issue guidance and requirements to ensure efficacy, public safety, and quality, ultimately protecting public health. Continued Process Verification (CPV) and Annual Product Quality Review (APQR) are essential regulatory practices that ensure the consistency and quality of manufactured products. CPV focuses on continuously monitoring the manufacturing process to maintain predefined quality standards, while APQR provides an annual review of a product's quality and associated processes. Both practices rely on similar data sources, such as process and product campaign data, quality event logs, and trend analyses. However, they are often managed separately, leading to inefficiencies, such as duplicate data collection and overlapping analysis. Integrating CPV and APQR workflows could reduce redundancy and improve overall efficiency. Furthermore, many companies still rely on manual mata collection and reporting, methods which hampers productivity. Adopting digital technologies, such as integrated informatics systems, can automate data gathering, enable real-time monitoring, and streamline regulatory reporting, enhancing operational efficiency and decision-making capabilities.