GMP / GCTP Annual Report
The Office of Manufacturing Quality for Drugs (OMQD), publishes the GMP/GCTP Annual Report, presenting its activities and achievements related to GMP inspection, the regulatory framework, international initiatives, current issues, and future perspectives.
In addition to the main body of the report, the FY 2023 and FY 2024 reports are accompanied by a “List of Identified Deficiencies”, which outlines the major deficiencies observed during GMP inspections conducted by PMDA in each fiscal year. All confidential information is appropriately anonymized.
- Attachment <4-3 List of Identified Deficiencies>[45.5KB]
- GMP / GCTP Annual Report FY 2023 [3.68MB](February, 2025)
- Attachment <5-3 List of Identified Deficiencies>[33.0KB]
- GMP / GCTP Annual Report FY 2022[1.08MB] (March, 2024)
To Our Readers: We Value Your Feedback
The GMP/GCTP Annual Report aims not only to enhance the transparency of PMDA’s activities, but also to promote mutual understanding between PMDA and pharmaceutical companies/regulatory authorities both in Japan and overseas.
In order to better tailor the content of the Report to the needs of our readers, we would greatly appreciate it if you could share your feedback through this questionnaire.
The questionnaire can be accessed via the URL or QR code provided below.
The deadline for responses is scheduled for March 31, 2026.
https://app.sli.do/event/7RE7Tz6rsSFYnWVe8q5oTo
Publication of Inspectional observations
From fiscal year 2022, PMDA started publishing GMP observations for which dissemination is considered particularly useful as warning and technical reference for the industry. The purpose of the publication is to promote voluntary efforts for quality improvements in pharmaceutical manufactures.
List of Rapid announcement of Inspectional observations
Observed Regulatory Attention / Notification of GMP Elements (Orange Letters)
- No.1 Failure to confirm adequacy of raw materials[118.71KB] (April, 2022)
- No.2 Risks associated with handling substances with unknown pharmacological activities and toxicities[185.26KB] (May, 2022)
- No.3 Overlooked risks to the quality of products due to insufficient CAPA[114.76KB] (July, 2022)
- No.4 Importance of thorough management of outsourced activities[170.49KB] (September, 2022)
- No.5 Improper recording[230.78KB] (December, 2022)
- No.6 Improper modification of records to align with instructions[262.68KB] (December, 2022)
- No.7 Mislabeling of the products caused by the violation of procedures[159.01KB] (March, 2023)
- No.8 Environmental monitoring in aseptic processing areas[127.64KB] (June, 2023)
- No.9 Handling of stability monitoring results[112.73KB] (July, 2023)
- No.10 English version is under preparation. (October, 2023)
- No.11 English version is under preparation. (October, 2023)
- No.12 English version is under preparation. (January, 2024)
- No.13 English version is under preparation. (March, 2024)