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.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

A Comprehensive Framework for GxP Compliance Across the Vaccine Lifecycle

  • Sanae Allam,
  • Adiba El Bouzekri El Idrissi,
  • Aicha Sekhari,
  • Yacine Ouzourt

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.