Series Overview

To encourage voluntary quality improvements and proactive compliance at pharmaceutical manufacturing sites, Japan’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), regularly publishes anonymized and highly practical findings from its GMP inspections. Released under the format known as the “Orange Letter” since 2022, these documents serve as vital references for life science professionals.

Rather than just listing regulatory violations, the series focuses on the root causes of compliance issues and shares real-world case studies based on the Japanese GMP Ministerial Order. The articles cover all the critical quality elements, such as material lifecycle management, sterile manufacturing controls, facility maintenance, and contamination control strategies (CCS). By reviewing these case studies, pharmaceutical professionals globally can enhance their quality assurance systems, better understand Japan’s regulatory expectations, and preemptively address similar compliance risks within their own manufacturing sites.

Published Articles

Below is the list of recently updated articles summarizing the PMDA Orange Letter findings. Please refer to the links for detailed case studies and catchwords:

• ● July 2026 Issue: Airflow Visualization Testing (Smoke Testing) in Aseptic Areas
• ● June 2026 Issue: Management of Expiration Date and Retest Period of API

* Note: This series is actively ongoing. Future articles will continue to be published and added to this list as they become available.