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2023/03/01 AD Quality System
The Initial Steps Toward Understanding GMP for Drugs: 3
1. Introduction In the previous article, I looked into ICH Q10 Pharmaceutical Quality System, a guideline covering the whole process of drugs from dev
2023/02/17 AD Quality System
Episodes on Quality Assurance: part 1
1. Impact on quality and determination of illegality At the end of March 2022, Kyowa Pharmaceutical was administratively ordered to suspend operatio
Episodes on Quality Assurance: part 3
Personnel Assignment and Quality System In order to ensure the quality of pharmaceutical products, it is widely recognized that it is important to sec
Episodes on Quality Assurance: part 2
Rationalization of manufacturing method description As a result of voluntary recalls due to discrepancies between the approval documents and actual ma
2023/02/07 AD Quality System
The Initial Steps Toward Understanding GMP for Drugs: 2
1. Introduction In my previous article, I wrote about the importance of seeing GMP as a system which ensures quality of drug products i.e. quality sys
2023/01/26 AD Quality System
The Initial Steps Toward Understanding GMP for Drugs: 1
1. Introduction Taking this opportunity to write a serial, I would like to provide our readers who are involved in GMP-related tasks from rookies to t
2025/01/23 AD
Findings related to discrepancies with approved dossier and fake record
PMDA ORANGE LETTER_2024.10
2025/05/15 AD
Deficiencies in multi-purpose manufacturing site
PMDA ORANGE LETTER_2025.01
AD
Ryoichi Tanaka
医薬品製造所に対する査察の各規制当局動向
Lily Yu
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