1.
Chem Pharm Bull (Tokyo)
; 69(2): 211-217, 2021 Feb 01.
Artículo
en Inglés
| MEDLINE
| ID: mdl-33298636
RESUMEN
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.