PMDA Pharmaceuticals and Medical Devices Agency, Japan

Announcement from Office of GMP/QMS Inspection

• Documents Required by PMDA for the Application of GMP Compliance Inspection Revised Version of Form 1-3 (Effective on January 1, 2011)
  (PDF)
• [Form1] (WORD)
• [Form3] (WORD)
• Documentation Required for the Application of Periodic GMP Compliance Inspection (Effective on January 1, 2011) (PDF)
• Annex1: Documentation Required for Periodic GMP Compliance Inspection (PDF)
• Documents required by PMDA for the Application of GMP Compliance Inspection (PDF)
• [Form3] Outline of Drug Manufacturing Site (Foreign Manufacturing Site) (WORD)

Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers

• GMP Compliance Inspection concerning Pharmaceuticals (including APIs) (PDF)
• Documents to be submitted for GMP Compliance Inspection (PDF)

Ministerial Ordinance on GMP

• Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative Translation :as of September 9,2005) [GMP] (PDF)

Others

• Flow of Complaints Handling (PDF)