药品连续制造中工艺疲劳的监管考量

Regulatory considerations for the process fatigue in pharmaceutical continuous manufacturing

药品连续制造已进入施行统一监管的全新发展时代,其将成为未来药品生产模式的大趋势和战略要求。尽管现有监管框架足以支撑药品连续制造技术的发展,但仍不能解决应用方面的具体问题。本文以长期运行下的连续生产工艺为主题,探究工艺疲劳对化学药、生物药及中药连续制造的影响,并提出相应监管考量。期望以此进一步聚焦连续制造技术在我国制药领域的实施困境,为我国药品连续制造的开发、实施、监管提供助力。促进ICH Q13指导原则尽早在我国落地转化,推动国内药品连续制造技术及先进生产技术的发展。

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.