A Comprehensive Framework for GxP Compliance Across the Vaccine Lifecycle
摘要
Ensuring compliance with regulatory requirements and managing data effectively are critical challenges in vaccine lifecycle management. This paper introduces a structured framework designed to ensure GxP regulations requirements, emphasizing regulatory alignment, data integrity, product efficacy and time optimization. The framework provides a unified structure that supports the integration of GxP compliance standards into the key stages of the vaccine lifecycle (from R&D and production to distribution) ensuring adaptability to evolving regulatory requirements. By addressing operational complexities and supporting decision-making, this approach lays the foundation for efficient implementation and audit readiness. Early insights highlight its potential to enhance lifecycle management practices in regulated industries.