2026/05/19 AD

Handling of Test Results Related to Stability Monitoring (Part 3)

PMDA ORANGE LETTER_2026.01

2026/02/26 AD

Addressing Personnel Shortages that Induce Human Error

PMDA ORANGE LETTER_2025.12

2026/01/08 AD Quality System

The Role of the QA Department

On Establishing the Required Structure for a Modern QA Department [Part 3]

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

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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]

2025/10/23 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

2026/01/08 AD Quality System

The Role of the QA Department

On Establishing the Required Structure for a Modern QA Department [Part 3]

2025/12/26 AD New Technologies

Nitrosamine Control in the Pharmaceutical Industry and an Innovative Environmental Control Solution.

Nitrosamine Control in the Pharmaceutical Industry and an Innovative Environmental Control Solution. - A Comprehensive Approach Focused on the Manufacturing Environment

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