文章基本信息

标题：Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing
本地全文：下载
作者：Hayato Ishimoto ; Manabu Kano ; Hirokazu Sugiyama 等
期刊名称：Chemical and Pharmaceutical Bulletin
印刷版ISSN：0009-2363
电子版ISSN：1347-5223
出版年度：2021
卷号：69
期号：2
页码：211-217
DOI：10.1248/cpb.c20-00824
出版社：The Pharmaceutical Society of Japan
摘要：As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology transfer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.
关键词：continuous manufacturing;control strategy;state of control;Quality by Design (QbD);solid drug product;regulatory science