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GMP
GMP WATCH NEWS – A Veteran’s Perspective
Paradigm Shifts in Pharmaceutical Quality Systems A Historical Review and Future Perspectives [Part 1] Introduction It has been nearly half a century since I first became involved in pharmaceutical GMP. During that time, GMP has evolved significantly, and unfamiliar GMP-related technical terms—such as “validation” and “qualification”—have been introduced. As GMP has evolved, I feel that the meanings and usage of these terms have shifted subtly. I wrote this article to clarify the meanings of these confusing terms by sharing stories from my own experience with GMP. I hope this helps readers understand that “GMP is not a law, but a...
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GMP
PMDA ORANGE LETTER_2026.07
ORANGE LETTER To encourage voluntary quality improvements at pharmaceutical manufacturing sites, Japanese regulatory agency PMDA has been publishing anonymized, highly useful findings from its inspections based on Japanese GMP Ministerial Order. These are published in a format known as the "ORANGE Letter" since 2022. CM Plus provides abridged English translations of the Orange Letters, for our clients' reference. Observed Regulatory Attention/Notification of GMP Elements LETTER Author: PMDA Issue: July 2026 Title: Airflow Visualization Testing (Smoke Testing) in Aseptic Areas Related GMP Ministerial Ordinance Clause: Article 24-3 Cases Defects in product contamination prevention control were observed. In a smoke test conducted...
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GMP
PMDA ORANGE LETTER_2026.06
ORANGE LETTER To encourage voluntary quality improvements at pharmaceutical manufacturing sites, Japanese regulatory agency PMDA has been publishing anonymized, highly useful findings from its inspections based on Japanese GMP Ministerial Order. These are published in a format known as the "ORANGE Letter" since 2022. CM Plus provides abridged English translations of the Orange Letters, for our clients' reference. Observed Regulatory Attention/Notification of GMP Elements LETTER Author: PMDA Issue: June 2026 Title: Management of Expiration Date and Retest Period of API - Preventing Misunderstandings Regarding Retest Related GMP Ministerial Ordinance Clause: Article 3-2, etc. Cases Due to insufficient understanding of the...
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![Fundamentals of Microbiology [Part 3]](https://cm-plus.co.jp/en/wp-content/uploads/2026/06/GMPP_cat_Others_14_e548213f52.jpg)
GMP
Fundamentals of Microbiology [Part 3]
This article is an updated 2026 version of the popular 50-part Japanese series “Microorganisms, Too Embarrassed to Ask Others About!” (いまさら人には聞けない！微生物のお話), previously published on GMP Platform*. Over the next several installments, I will explore a wide range of topics related to microorganisms, from the fundamentals to more in-depth insights that are not widely known even among professionals in the field. Previously... - Fundamentals of Microbiology [Part 2] Properties of Microorganisms Microorganisms play an extremely important role in decomposing substances in the Earth's environment. If microorganisms did not exist and substance decomposition did not occur, we should be able to...
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GMP
Fundamentals of Microbiology [Part 2]
This article is an updated 2026 version of the popular 50-part Japanese series “Microorganisms, Too Embarrassed to Ask Others About!” (いまさら人には聞けない！微生物のお話), previously published on GMP Platform*. Over the next several installments, I will explore a wide range of topics related to microorganisms, from the fundamentals to more in-depth insights that are not widely known even among professionals in the field. Previously... - Fundamentals of Microbiology [Part 1] We Live Surrounded by Microorganisms Individual microorganisms are very small and cannot be seen with the naked eye, so we rarely are aware of their existence in daily life. However, unless in...
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GMP
Fundamentals of Microbiology [Part 1]
This article is an updated 2026 version of the popular 50-part Japanese series “Microorganisms, Too Embarrassed to Ask Others About!” (いまさら人には聞けない！微生物のお話), previously published on GMP Platform*. Over the next several installments, I will explore a wide range of topics related to microorganisms, from the fundamentals to more in-depth insights that are not widely known even among professionals in the field. Microorganisms: The Basics of Basics The Earth was born approximately 4.6 billion years ago, and primitive life is said to have appeared about 600 million years after the Earth's birth, that is, about 4 billion years ago. Early life...
