2023/03/03 AD Manufacturing(GMDP)
Regulatory and compliance challenges for local and regional manufactures in the ASEAN
【Information on services related to this article】 In general there are three types of players in the ASEAN regulated healthcare industries who ha
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
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
2025/11/14 AD
Deficiency in Sterility Assurance by Sterilization Validation
PMDA ORANGE LETTER_2025.08
2025/08/05 AD
Problems Behind Discrepancies with product authorization requirements
PMDA ORANGE LETTER_2025.05
2025/07/15 AD
PMDA ORANGE LETTER_2025.03
2025/01/23 AD
Findings related to discrepancies with approved dossier and fake record
PMDA ORANGE LETTER_2024.10
AD
医薬品の技術移転のポイント【第3回】
Morio Wakisaka
Ryoichi Tanaka
You will be navigated to the CM Plus company website.
CM Plus Group Website