2025/11/14 AD

Deficiency in Sterility Assurance by Sterilization Validation

PMDA ORANGE LETTER_2025.08

2025/10/23 AD Quality System

What the Revised GMP Ministerial Ordinance changed.

On Establishing the Required Structure for a Modern QA Department [Part 2]

2025/09/03 AD Quality System

What the Revised GMP Ministerial Ordinance changed.

On Establishing the Required Structure for a Modern QA Department [Part 1]

2025/08/06 AD Quality System

Fact from 2,500 of FDA Form 483s

Data Integrity Issue Trend on FDA Inspections

2025/08/05 AD

Problems Behind Discrepancies with product authorization requirements

PMDA ORANGE LETTER_2025.05

2025/07/15 AD

Deficiencies in multi-purpose manufacturing site

PMDA ORANGE LETTER_2025.03

2025/05/15 AD

Deficiencies in multi-purpose manufacturing site

PMDA ORANGE LETTER_2025.01

2025/01/23 AD

Findings related to discrepancies with approved dossier and fake record

PMDA ORANGE LETTER_2024.10

2025/10/23 AD Quality System

What the Revised GMP Ministerial Ordinance changed.

On Establishing the Required Structure for a Modern QA Department [Part 2]

2025/08/06 AD Quality System

Fact from 2,500 of FDA Form 483s

Data Integrity Issue Trend on FDA Inspections

2025/09/03 AD Quality System

What the Revised GMP Ministerial Ordinance changed.

On Establishing the Required Structure for a Modern QA Department [Part 1]

2025/05/15 AD

Deficiencies in multi-purpose manufacturing site

PMDA ORANGE LETTER_2025.01