GMP / GCTP Annual Report
The Office of Manufacturing Quality for Drugs (OMQD), PMDA summarizes the Business accomplishment related to GMP inspection, regulatory system, international activities, current issues, future vision, etc., to issue a GMP/GCTP Annual Report.- GMP / GCTP Annual Report FY 2022[1.08MB] (March, 2024)
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)