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Quality Assurance Activities

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)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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Quality Assurance Activities