This article is based on a case study for obtaining the Notified Body Opinion of a staked needle glass syringe pre-filled with a vaccine, produced by an Asian pharmaceutical industry and registered in Europe.

We will follow step by step the filing of the technical dossier, which documents to request from suppliers and which information to provide to the Notified Body.

This document will be a useful guide for the applicant to reduce the time and costs of applying a device constituent of a combined product according to the Art.117 of EU 2017/745.

Our group has studied the ideal state of deviation control and CAPA handling at the pharmaceutical manufacturing. It is important to detect minor deviations and incidents earlier and respond promptly, which promotes “Speak-up” culture and allocating resources according to the risk of the deviations.

This paper proposes a Double-Loop Method for managing incidents according to the procedure that investigation, disposition whether it is an incident or not, PDCA cycle will be implemented with record of incidents, list as deviation, and observing incidents.

Two examples of incidents are introduced for deeper understanding. One is packaging abnormalities of raw material, and the other is data loss in environmental monitoring systems.

Digital technologies and artificial intelligence (AI) are rapidly advancing in the field of pharmaceutical manufacturing, bringing about dramatic transformations within the industry. Member companies of the Japan PDA Pharmaceutical Association have also been actively adopting digital transformation (DX), and lively discussions on DX were held during individual committee sessions at the 2023 Annual Meeting. Based on this experience, at the 2024 Annual Meeting, the Association consolidated these previously separate committee discussions into a unified, three-and-a-half-hour joint symposium titled “Transforming Pharmaceutical Manufacturing through Digital Technology and AI.” This paper reports on the Committee Joint Symposium held on Thursday, December 5, 2024, during the Japan PDA Pharmaceutical Association 2024 Annual Meeting.