{"id":6468,"date":"2026-08-25T00:00:46","date_gmt":"2026-08-24T15:00:46","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?post_type=column&p=6468"},"modified":"2026-08-24T17:42:29","modified_gmt":"2026-08-24T08:42:29","slug":"2026_0825","status":"publish","type":"column","link":"https:\/\/cm-plus.co.jp\/en\/column\/gmp\/2026_0825\/","title":{"rendered":"GMP WATCH NEWS – A Veteran’s Perspective"},"content":{"rendered":"

Paradigm Shifts in Pharmaceutical Quality Systems
\nA Historical Review and Future Perspectives [Part 1]<\/strong><\/span><\/p>\n

Introduction<\/strong><\/span>
\nIt 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\u2014such as \u201cvalidation\u201d and \u201cqualification\u201d\u2014have 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 \u201cGMP is not a law, but a science for ensuring quality.\u201d<\/p>\n

The Birth of GMP<\/span>
\n<\/strong>I\u2019m sure many of you have felt frightened after seeing news reports of mobile batteries suddenly catching fire inside carry-on luggage on planes or trains. While factors such as the product being subjected to a strong impact could be causes of the fire, I understand that in many cases, the user is not at fault. According to news reports, there is no doubt that changes in manufacturing processes resulting from intense price competition are a contributing factor to these accidents. I am shocked\u2014and even angered\u2014by the fact that companies, which should be responsible for product quality, do not know where the parts were made or how the products were assembled, and by their lack of a proper response.
\nHowever, even in the Japanese pharmaceutical industry several decades ago, efforts to improve processes with the aim of reducing costs and enhancing quality were encouraged. While process yield and productivity did indeed improve, these changes were not managed in accordance with established rules. As a result, situations arose where it was unclear when, by whom, or how changes had been made. Although manufacturing instructions did exist, they were not updated every time a change was made, and there were instances where\u3000products were being manufactured using a method that differed from the original one.
\nUnder these circumstances, from the late 1950s to the early 1960s, a serious drug-related disaster involving the sleeping pill \u201cthalidomide\u201d occurred on a global scale. Although it was a tragic incident, it served as a catalyst for mandating proof of a drug\u2019s \u201cefficacy\u201d and granting the FDA the authority to establish manufacturing standards, leading to the introduction of Good Manufacturing Practice (GMP) for pharmaceuticals. This occurred in 1963. More than half a century has passed since the FDA introduced GMP. Now GMP has become a global standard for science-based quality assurance, playing a significant role in improving the quality of pharmaceuticals. The FDA expects the pharmaceutical industry to pay close attention to GMP-related announcements issued by the agency and to manufacture pharmaceuticals in compliance with the latest GMP standards; for this reason, it specifically uses the term \u201cCGMP\u201d\u2014adding the \u201cC\u201d for \u201cCurrent\u201d\u2014rather than simply \u201cGMP.\u201d\u3000I feel the FDA’s pride in leading global GMP standards in the fact that it added a \u201cC\u201d to the acronym GMP.
\nMore than half a century has passed since the FDA introduced GMP. Now GMP has become a global standard for science-based quality assurance, playing a significant role in improving the quality of pharmaceuticals. The FDA expects the pharmaceutical industry to pay close attention to GMP-related announcements issued by the agency and to manufacture pharmaceuticals in compliance with the latest GMP standards; for this reason, it specifically uses the term \u201cCGMP\u201d\u2014adding the \u201cC\u201d for \u201cCurrent\u201d\u2014rather than simply \u201cGMP.\u201d\u3000I feel the FDA’s pride in leading global GMP standards in the fact that it added a \u201cC\u201d to the acronym GMP.<\/p>\n

From Quality Control to Quality Assurance<\/span>
\n<\/strong>While there appear to be various GMP standards around the world\u2014such as CGMP, WHO GMP, PIC\/S GMP, and EU GMP\u2014they are essentially the same in that their purpose is to ensure that high-quality medicines are delivered to patients.\u3000Although the wording of GMP regulations varies from country to country, GMP is a set of fundamental rules that pharmaceutical manufacturers must follow to prevent the production of defective medicines caused by manufacturing processes and to ensure that such products are not released to the market even if they are produced.
\nThe manufacturing department performs and records operations in accordance with the SOPs (Standard Operating Procedures) for manufacturing, while the quality control department checks the quality of raw materials, intermediates, and finished products in accordance with the SOPs for quality testing and records the results. A designated person reviews both records and determines whether the product is acceptable for release. This quality assurance method, based on this ultimate double-check system, has remained unchanged since the inception of GMP, and I believe it will remain so in the future.
\nWhile GMP is a rule that manufacturers must adhere to, it is the role of management to foster a culture in which everyone involved in the manufacture of pharmaceuticals works with the mindset of delivering better medicines to patients; this is the final goal of GMP.<\/p>\n

Because the company I worked for exported active pharmaceutical ingredients to the United States, we were able to undergo an FDA inspection relatively early on for a Japanese company. I was fortunate that this inspection experience allowed me to recognize the importance of accountability behind GMP. I vividly recall how, despite having undergone a mock inspection by the company to which we exported the active pharmaceutical ingredient and believing we had thoroughly prepared for the FDA inspection, the inspectors discovered during the inspection that our process parameters differed from the values listed in the Drug Master File. When asked to explain the reason for the change in the manufacturing process, I found myself at a loss for words. At the time, while we were confident in the high quality of our products, we didn\u2019t pay much attention to change control. Since it was a minor change, it didn\u2019t lead to any major issues, but it was a close call. Going through an FDA inspection made me realize just how important GMP was back then. I\u2019ll skip the details, but I recall that once GMP became a regulatory requirement, it began to take root in Japan in the 1990s. GMP training sessions were held frequently, attracting large numbers of participants and creating a lively atmosphere.<\/p>\n

While pharmaceuticals and mobile batteries are similar in that their quality can be a matter of life and death, there is a significant difference in how quality is ensured. With pharmaceuticals, it is not possible to guarantee quality through 100% inspection without destroying the products; however, with industrial products such as mobile batteries, it is theoretically possible to guarantee product quality through 100% inspection without destroying the products. In this sense, the manufacturer\u2019s liability is clear in the event of a fire caused by a defective battery. Therefore, rules similar to GMP should be introduced in battery manufacturing as well.<\/p>\n

Since it is generally impossible to perform non-destructive 100% inspection on pharmaceuticals, the quality of the final product was traditionally checked through sampling. However, in the early 1970s in the United States, a tragic incident occurred in which sepsis caused by bacterial contamination in intravenous solutions resulted in numerous deaths. Although the products had passed sampling inspections prior to shipment, the accident was caused by bacteria contaminating some of the bottles. This incident led to the realization that \u201ceven safety cannot be ensured unless the manufacturing process itself is properly controlled, even if the product passes sampling inspections.\u201d Consequently, there was a growing demand to shift from \u201cquality control that checks finished products\u201d to \u201cquality assurance that scientifically proves that products will always meet standards if manufactured according to predetermined procedures.\u201d In response to this situation, the FDA issued guidelines titled \u201cGeneral Principles of Process Validation\u201d in 1987, which had a significant impact on the world of GMP.<\/p>\n

\n

Author<\/strong><\/p>\n

\n
\"\"<\/div>\n
Akio Nakao, Ph.D.<\/a>
\nNakao started his career in 1976 at Tanabe Seiyaku Co., Ltd. After carrying out research in synthetic organic chemistry and process chemistry (industrialization) at the company, he successively took the positions of quality assurance manager, director and general manager of production, and managing director in charge of management planning. After Tanabe merged with Mitsubishi to become Mitsubishi Tanabe Pharma Corporation, Nakao became Managing Executive Officer and Chief Director of Medicine Manufacturing. Through his experience in dealing with FDA inspections and activities at the Parenteral Drug Association (PDA), Nakao became convinced that GMP is an “exact science.”
\nFinding that his beliefs were reflected in CM Plus Corporation’s enthusiasm for improving GMP education, Nakao joined CM Plus in 2011 as a Director and be promoted as executive vice-president in 2012. Fellow since July 2017.<\/div>\n<\/div>\n

About GMP Platform<\/strong> (<\/span>https:\/\/www.gmp-platform.com\/<\/a><\/span>)<\/span><\/p>\n

\n
\"\"<\/div>\n
GMP Platform is a free GMP-related information portal established in 2012 and operated by CM Plus Corporation. Built on CM Plus\u2019s founding principle of addressing quality-related issues in life science facilities, the site provides practical, expert-led information for life science manufacturing professionals. With more than 26,000 registered users, GMP Platform introduces the latest GMP-related regulations and trends in Japan, the United States, Europe, and other regions, along with translated and explanatory articles on guidelines, technical articles, seminars, e-learning programs, and books. It is widely used by professionals involved in GMP compliance, quality assurance, and the development of effective quality systems.Please use Google Translate or similar translation tools to read more articles originally published in Japanese.
\n*If you are using Google Chrome, right-click and select “Google Translate” on the article.<\/div>\n<\/div>\n","protected":false},"featured_media":6469,"template":"","columncat":[61],"columntag":[],"keywords":[11],"acf":[],"yoast_head":"\nGMP WATCH NEWS - A Veteran's Perspective\uff5cCM Plus<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/en\/column\/gmp\/2026_0825\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GMP WATCH NEWS - A Veteran's Perspective\uff5cCM Plus\" \/>\n<meta property=\"og:description\" content=\"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. 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