Challenge for Stable Production on Oral Formulation Manufacturing Process

Hiroki Tango; Michio Shiotsu; Kohei Yamauchi; Keiji Imai

doi:10.4164/sptj.53.564

Review

Challenge for Stable Production on Oral Formulation Manufacturing Process

Hiroki Tango, Michio Shiotsu, Kohei Yamauchi, Keiji Imai

Author information

Keywords: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH） Q trio, Process Analytical Technology （PAT), Critical Process Parameter （CPP）, Critical Material Attribute （CMA）, Critical Quality Attribute （CQA）

JOURNAL RESTRICTED ACCESS

2016 Volume 53 Issue 9 Pages 564-570

DOI https://doi.org/10.4164/sptj.53.564

Details

Abstract

Demand on generic drug is being increased recently, and high quality level and stable supply are required to generic pharmaceutical company as well as innovative pharmaceutical company. To achieve that, implementation of ICH Q trio is necessary. Implementation of ICH Q trio should be considered in R&D development phase, but for legacy product, it has to be done in production phase. PAT and QbD approach support these challenge on legacy product. At this time, several examples are introduced about how to achieve these challenges in Takayama plant of Teva.

Corresponding author

Register with J-STAGE for free!