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
2024/03/13 AD Regulation
China NMPA’s observations of ‘flight inspection’ on medical devices
2024/02/26 AD Others
Microorganisms、too embarrassed to ask others about!(Part 13)
2023/11/22 AD Others
Microorganisms、too embarrassed to ask others about!(Part 11)
2024/04/03 AD Others
Microorganisms, too embarrassed to ask others about!(Part 14)
2024/01/12 AD Others
Microorganisms、too embarrassed to ask others about!(Part 12)
2023/11/29 AD
PMDA ORANGE LETTER_2023.10
2023/11/13 AD
PMDA ORANGE LETTER_2023.7
AD
Yasuto Koyama
Shunichi ASAI
Yumiko MIYAZAWA
Wataru Ohashi
ドマさんの徒然なるままに【第29話】
Doma Furuta
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