Allison Gretchen, Cain Yanxi Tan, Cooney Charles, Garcia Tom, Bizjak Tara Gooen, Holte Oyvind, Jagota Nirdosh, Komas Bekki, Korakianiti Evdokia, Kourti Dora, Madurawe Rapti, Morefield Elaine, Montgomery Frank, Nasr Moheb, Randolph William, Robert Jean-Louis, Rudd Dave, Zezza Diane
J Pharm Sci. 2015 Mar;104(3):803-12.
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
本文评估了当前的监管环境、相关法规和指南及其对连续制造的影响。它从审评和检查的角度总结了当前的监管经验和认识。它概述了关键的监管方面，包括监管文件中的连续制造工艺描述和控制策略、工艺验证以及关键的药品生产质量管理规范（GMP）要求。此外，本文还识别了监管差距和挑战，并提出了促进实施的前进方向。
