Quality & Technology Committee Task Force (TF) for Promoting Digital Transformation of Commercial Manufacturing (DX) Case Study Q&A
The JPMA Quality & Technology Committee launched the Task Force (TF) to Promote Digital Transformation (DX) in Commercial Production and began discussions based on the recognition that while digital transformation (DX) in commercial production is an important means to improve quality and ensure stable supply, the industry's common issues, trends with authorities, and discussions regarding operational standardization are not yet fully organized and shared. (TF) was established and started to study the issue. As part of its activities, the TF collected issues related to the use of digital technology (including AI) from pharmaceutical companies through a questionnaire to ascertain the status of their initiatives, and compiled ideas for solving issues and leading examples in a Q&A format based on publicly available case studies and related guidelines.
In the utilization of computerized systems and AI, it is important to make decisions based on quality risk management and to manage them throughout their lifecycle. The purpose of this document is to visualize issues common to the industry and provide hints on how to respond to them that can be used as a reference when examining them in practice at each company. We hope that it will be of some help in the utilization of digital technology (including AI) by each company.
- *This document is provided as reference information only, and is not intended to recommend specific measures or decisions. Each company is responsible for determining its own specific measures based on relevant laws and regulations, regulatory requirements, and its own quality management system. The case studies and linked information provided are based on publicly available information from each company and do not represent the validity of individual cases or the views of the regulatory authorities.