The Initial Steps Toward Understanding GMP for Drugs: 3

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

Episodes on Quality Assurance: part 1

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

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

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

The Initial Steps Toward Understanding GMP for Drugs: 2

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

The Initial Steps Toward Understanding GMP for Drugs: 1

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