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]
1.4 Stability Monitoring (GMP Ministerial Order Article 11-2) When it comes to stability monitoring, many people likely envision the process of collec
2025/09/03 AD Quality System
On Establishing the Required Structure for a Modern QA Department [Part 1]
My name is Ryoichi Tanaka. Until the end of June 2024, I worked as a civil servant at the Kyoto Prefectural Government for about 18 years. For 11 of
2025/08/06 AD Quality System
Fact from 2,500 of FDA Form 483s
Data Integrity Issue Trend on FDA Inspections
Fact from 2,500 of FDA Form 483s This article is a translation of a Japanese article published on 「PHARM TECH JAPAN Vol.41 NO.6(2025)」. Introduction T
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
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Deficiencies in multi-purpose manufacturing site
PMDA ORANGE LETTER_2025.01
2025/11/14 AD
Deficiency in Sterility Assurance by Sterilization Validation
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2025/08/05 AD
Problems Behind Discrepancies with product authorization requirements
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2025/07/15 AD
PMDA ORANGE LETTER_2025.03
2025/01/23 AD
Findings related to discrepancies with approved dossier and fake record
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AD
医薬品の技術移転のポイント【第3回】
Morio Wakisaka
Ryoichi Tanaka
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