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GMP WATCH NEWS – A Veteran’s Perspective［2］ Paradigm Shifts in Pharmaceutical Quality Systems A Historical Review and Future Perspectives [Part 2] Implementation of Process Validation The concept of validation has its roots in the space technology developed during the U.S. Apollo program (1960s). Launch rockets are single-use. The concept of sampling inspection—where one might say, “Let’s test-launch it; since it worked, we’ll launch it again”—simply does not apply. Therefore, NASA rigorously applied the principles of reliability engineering—the idea that “if the design and manufacturing processes are flawless, the final product must also be flawless”—and established the prototype for the concept of validation. FDA officials wondered, “Why isn’t...
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...
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...
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...
GMP
Fundamentals of Microbiology [Part 5] History of Microbiology 2-2 After Pasteur's negation of the theory of spontaneous generation in the mid-19th century, many studies were conducted on the relationship between diseases and microorganisms, deepening the understanding of what we now call infectious diseases. Heinrich Hermann Robert Koch of Germany discovered anthrax bacteria, tuberculosis bacteria, and cholera bacteria. He also established a pure isolation method for bacteria that was not possible before. Koch's postulates, the basic guidelines proposed by Koch to prove the pathogen of an infectious disease, are still used today to prove the causal relationship in infectious diseases. Koch’s Postulates (Quoted from Wikipedia) 1. ...
GMP
Fundamentals of Microbiology [Part 4] 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 3] History of Microbiology 2-1 Microorganisms existed long before the appearance of humans, as well as many ancient organisms we know such as dinosaurs and trilobites on Earth. Some dinosaur fossils show clear...
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...
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...
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...

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