Regulatory considerations for the process fatigue in pharmaceutical continuous manufacturing
CAO Zhuang-ning
HUANG Zhe
Abstract：Pharmaceutical continuous manufacturing has entered a new development era of unified supervision.It will become the general trend and strategic requirement for the future drug production models.While the existing regulatory framework is adequate to support this development,it cannot address the specific issues raised during applications.Concentrating on continuous manufacturing processes under long-term operation,this paper examines the impact of process fatigue in the continuous manufacturing of chemical drugs,biological drugs,and traditional Chinese medicine,as well as corresponding regulatory considerations.This paper will focus on the implementation dilemmas of continuous manufacturing technologies in Chinese pharmaceutical industries and provide assistance in the development,implementation and regulation of the technologies in China.The transformation and implementation of ICH Q13 guidelines need to be promoted expeditiously in China,and the development of domestic continuous manufacturing technologies and advanced production technologies demands immediate action.
Keywords：pharmaceutical continuous manufacturingprocess fatigueregulatory considerations
Publication Date：2024-02-29
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 407-411 )