GMP compliance inspection

Regulations and Guidelines

Regulations

• Ministerial Order on the Standard of Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-Pharmaceuticals [309.6KB] (Tentative Translation updated Jun 21, 2024)
• Ministerial Order on the Standard of Quality Management for Pharmaceuticals, Quasi-Pharmaceuticals, Cosmetics, and Regenerative Medicine Products [118KB] (Excerpt) (Tentative Translation updated Jul 1, 2024)
• Regulations of Buildings and Facilities of Pharmacies, etc. [1.02MB]
• Notification Concerning Partial Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality control for Drugs and Quasi-drugs (April 28, 2021) [668.60KB] (English version is under preparation.)

Administrative Notice on Application of PICs GMP Guide

• Administrative Notice on Application of PICs GMP Guide(February 1, 2012) [1.31MB]
• Q and A(February 1, 2012) [83.47KB]

Guideline on Management of Computerized Systems

• Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (Effective on October 21, 2010) [140.88KB]
• Q & A [91.85KB]

Guidance on the Manufacture of Sterile Pharmaceutical Products

• Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing (When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic.) [696.52KB]

SMF(Site Master File) template

• PDF [377.82KB]
• word [32.0KB]

This SMF template was discussed at APAC (Asia Partnership Conference of Pharmaceutical Associations) meeting with Asian regulatory authority such as Indonesia, South Korea, Taiwan and Thailand and we reached conclusion to promote usage of this template. This is a reference to the manufacturing sites to prepare the SMF. Whenever you apply this SMF template to your manufacturing sites, please modify this to the present condition of your sites.

Overview Guidances and Notifications concerning GMP compliance inspection

Overview Guidance of GMP Compliance Inspection

• ​GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufactures(September 26, 2023)
• Legal authorities of GMP inspections in Japan [152.32KB]

Documents for application of GMP inspection

• Documents to be submitted for the application for GMP compliance inspection (Aug.2 ,2023) [1.78MB] (English version is under preparation.)

Others

• Flow of Complaints Handling [117.88KB]

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Quality Assurance Activities

Publication of Inspectional observations
Observed Regulatory Attention / Notification of GMP Elements (Orange Letters)

• List of Rapid announcement of Inspectional observations