To pass on the expertise of skilled workers, it is essential to verbalize the information they possess. Although the utilization of digital transformation (DX) technologies, such as wearable devices, is progressing, various factors hinder their widespread adoption. These include restrictions on bringing digital devices into certain work environments, such as explosion-proof areas and sterile rooms, as well as the cost-effectiveness of purchasing equipment and developing programs.

Furthermore, how to utilize the formalized knowledge obtained to guide new employees is still a trial-and-error process in every industry.

This article reports on an attempt to formalize the skills of visual inspectors of vial formulations using eye-tracking technology and interviews. It also discusses the outcomes of using the obtained information to train new employees quickly (rapidly).

Continuous manufacturing (CM) involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process. Although the ICH Q13 guideline that describes scientific approaches and regulatory considerations specific to CM has been issued, additional information about injections must be provided. Therefore, to promote the application of CM to injections, a Japan Agency for Medical Research and Development (AMED) research group, consisting of members from industry, academia, and the regulatory authorities, was set up to examine CM model cases for injections and establish control strategies and other technical considerations and summarize them as a Points to Consider document. This paper presents the points to consider in CM of injections which are model cases of terminal sterilization or aseptic processing, and lyophilized drug products.

Voluntary recalls of prescription drugs owing to quality issues have recently increased in Japan and are contributing to a large-scale drug shortage. In this study, we investigated and examined drug recall information to identify potential quality-related issues.

We investigated class I and class II recalls of prescription drugs (class I: 43 items; class II: 1232 items) from 2016 to 2022. We found that among class I recalls, 95% of the drugs was recalled for quality-related reasons, whereas in class II recalls, 44%, 46%, and 5% of the items were recalled for quality-related reasons, violation-related reasons, and both quality-related and violation-related reasons, respectively. Among quality-related reasons for class II recalls, non-conformance to approved specifications, such as dissolution, content, and purity, was the most common (387 items), and approximately 80% of these cases were identified through stability monitoring or other stability tests, suggesting a decrease in stability. Among them, 53 items failed to comply with approved specifications within one year of manufacture, suggesting that they are not manufactured at sufficient quality levels that guarantee shelf life. Furthermore, the investigation of violation-related reasons suggested that there may be cases where release specifications were unmet owing to violation-related reasons, such as insufficient verification leading to retest.

Such quality problems are considered to be resulting from insufficient consideration of critical quality attributes and critical process parameters at the development stage, in addition to various changes during the lifecycle. Therefore, sufficient consideration must be given to maintain consistency in quality for each item.

The Japan Agency for Medical Research and Development (AMED)'s initiative for regulatory harmonization and evaluation has conducted collaborative research projects spanning industry, government, and academia. This initiative focuses on “Research for the quality and process control for pharmaceutical continuous manufacturing.” A notable project under this initiative has investigated “A feasibility research for Multivariate Statistical Process Control (MSPC) in continuous manufacturing of solid dosage formulation” since 2021. To ensure “State of Control” in continuous manufacturing, one approach is to continuously monitor and control Critical Quality Attributes (CQA) and/or Critical Material Attributes (CMA) using Process Analytical Technology (PAT) such as near-infrared spectroscopy. However, challenges, including low API content and technical hurdles in high-frequency real-time monitoring, sometimes make PAT-based control impractical. This study has examined the feasibility of MSPC, which enables simultaneous monitoring of multiple factors of the manufacturing process, as an alternative tool for anomaly detection within the control strategy for continuous manufacturing. The investigation has identified both technical and regulatory challenges. To clarify the way for strategic integration of MSPC into control strategy and description in CTD, the research team developed “CTD mock-up document of the case study for the implementation of the Multivariate Statistical Process Control (MSPC) in the continuous manufacturing process for oral solid dosage form.” The control strategy presented in this mock-up document is just one example, and it should be noted that other approaches are also feasible.