过程分析技术的相关法规与工具在制药行业中的应用进展  

Regulation Tools and Application Progress of Process Analysis Technology in Pharmaceutical Industry

作　　者：谢升谷 黄艳[2] 孙逍 郑金琪 陶巧凤 XIE Sheng-gu;HUANG Yan;SUN Xiao;ZHENG Jin-qi;TAO Qiao-feng(NMPA Key Laborator jor Core Technology of Generic Drug Evaluation,Zhejiang Province Key Laboratory for Drug Contacting Material Quality Control,Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Zhejiang University of Technology,Hangzhou 310014,China)

机构地区：[1]浙江省食品药品检验研究院,国家药品监督管理局仿制药评价关键技术重点实验室,浙江省药品接触材料质量控制研究重点实验室,杭州310052 [2]浙江工业大学,杭州310014

出　　处：《中国药学杂志》2022年第19期1589-1595,共7页Chinese Pharmaceutical Journal

基　　金：浙江省药品监督管理局科技计划资助(2021005);浙江省药品监督管理与产业发展研究会课题资助(ZYH2021003);浙江省医药科技计划面上项目资助(2020ky529)。

摘　　要：随着过程分析技术(process analysis technology,PAT)在制药行业越来越受到重视,美国食品药品监督管理局(FDA)等官方机构正在积极推动应用PAT技术,力图从过程、工艺上保证产品的质量,改变目前主要依靠认证认可检查的现状。本文综述了制药行业中的PAT相关法规/指导原则发展进程以及常用的PAT工具和相关应用进展,为加强我国制药行业对PAT的理解提供一定参考,推动制药企业将其融入生产过程,从药品质量的源头抓起,提高药品质量。As process analytical technology(PAT)is getting more and more attention in the pharmaceutical industry,official agencies including the FDA are actively promoting the application of PAT,trying to ensure the quality of products from manufacturing process and technique,and change the current situation that can only rely on strict and blunt certification specifications.This paper reviews the development process of PAT-related regulations/guidance principles in the pharmaceutical industry,as well as the commonly used PAT tools and related application progress,to provide a certain reference for strengthening the understanding of PAT indomestic pharmaceutical industry,and to promote pharmaceutical companies to integrate it into the production process to seize the source and improve the quality of medicines.

关 键 词：过程分析技术 制药行业 法规 指导原则 

分 类 号：R944[医药卫生—药剂学] R969[医药卫生—药学]