A glimpse of the current situation of Japanese Kampo medicine from the new regulations of Tsumura Pharmaceutical

Although Japan formally joined PIC/S in 2014, there have always been some differences between Japanese GMP and PIC/S regulations. It is embodied in the following six aspects.

  • Considering quality risk verification implementation
  • Import annual review (product quality survey)
  • Stability test monitoring
  • Storage of reference products containing raw materials
  • Management of raw material manufacturers
  • Correspondence to the concept of risk management

In order to eliminate these differences as much as possible, the Japanese government is constantly revising Japanese GMP regulations content. At the same time, we have also seen that some companies are actively cooperating to respond to the new PIC/S regulations. TSUMURA ??(Tsumura Co., Ltd.) conducted stability tests under the severe conditions required by PIC/S. Based on the results, the validity period of all Kampo preparations under its company will be revised in October 2020. The specific change is to shorten the validity period from 5 years to 3 years. This article will specifically discuss its background and the purpose behind it, and use this article to learn more about the efforts of Japan’s largest Kampo medicine company in pursuing product quality.

1. The existence of PIC/S is more as a “reference” PIC/S is a country An informal agreement organization between GMP administrative agencies, the purpose of which is to promote international consistency in quality management. PIC/S is mainly responsible for the development of GMP guidelines (GL) for national common standards, as well as the final unification of international audit standards based on training and education of auditors of various countries. In view of the fact that PIC/S itself is an informal group organization, various countries have different views on PIC/S, and there is basically no mandatory binding f China Phenibut orce. The GMP GL of PIC/S in Japan is also used as a reference, not an obligation. Regarding the effectiveness, safety, and quality of the drug, the pharmaceutical company shall, on the basis of self-accountability, scientifically prove it, and obtain a production and sales license from PMDA (Japan Food and Drug Administration) based on the results Application. PMDA reviews and approves this. The same is true for the stability of medicines. Pharmaceutical companies must scientifically and reasonably prove that the quality of the medicines produced can remain stable after a period of time. However, PMDA has no precise regulations on how to ensure product quality, but it is up to companies to judge how to conduct scientific demonstrations. The quality of medicines is easily affected by temperature and humidity. In the past, Tsumura conducted stability evaluations based on the approved stability test results under the premise of natural changes in the temperature of the storage site. In 2012, before Japan joined the PIC/S, Tsumura began to independently implement the stability test of the ICH standard. Under more severe conditions than the approved conditions (temperature 25±2°C, humidity 60±5%RH), the content of the quantitative components contained in Kampo was monitored. The results were summarized in 2019. Although some of the component results were within the standard range, the component content decreased after 5 years. Tsumura hopes to provide the market with products that guarantee a certain quality, and their quality and production will not change. Therefore, after careful discussion, the company took the initiative to shorten the validity period of its products to three years (except for Dajianzhongtang, which is valid for three years), which is the news content mentioned in the title of this article. 2. Move the whole body together, this als Buy Phenibut Online o caused criticism In response to the shortening of the product expiration date, some pharmacies responded to the This complained. Nevertheless, the Ministry of Health, Labour and Welfare considers the case of Tsumura to “actively respond in accordance with stricter international standards.” On the other hand, what should other pharmaceutical companies do? The Ministry of Health, Labour and Welfare also responded to this, “For product stability monitoring, even if it does not comply with PIC/S, it will not be judged as a violation of the Pharmaceutical Machinery Act or GMP regulations. More importantly, companies need to know how to scientifically Carry out production management.” As for the stability tests carried out by other companies, it is difficult for others except companies to know. According to an interview with the Kampo Pharmaceutical Association of Japan, the association stated that “it has not received any inquiries from member companies on the change of the expiration date. If it is necessary to modify the expiration date, each company can make changes on its own.” Kracie Pharmaceuticals, which has the second largest market share of medicinal Kampo, also responded to this incident, saying that “the original company’s products have a validity period of three years”, “there are stability monitoring data now, and there is no impact yet.” If necessary, the company will seriously discuss and respond.” 3. Higher pursuit of product quality Why Tsumura’s PIC/S regulations are not just for reference, but based on PIC /S Regulations have implemented stability tests and shortened the validity period of products? Tsumura believes that even before Japan joined PIC/S, the company had a strong sense of product quality. The effectiveness and safety of Kampo medicine are greatly affected by the quality of crude drugs. The quality o Phenibut powder wholesale f crude drugs varies according to the cultivation conditions and climatic conditions of medicinal plants. For this reason, before Japan joined PIC/S, Tsumura established a strict quality assurance system (refer to the Tsumura quality system diagram below), which can be traced back to what crude drug raw materials are used, where the manufacturer produces and conducts What kind of cultivation. Fixing the place of production and instructing producers on cultivation methods can effectively suppress the fluctuation of the active ingredients contained in crude drugs. Even so, the ingredients will fluctuate. For this, Tsumura has established a management system based on the ingredient data contained in the batches of crude drugs to strictly ensure that the balance of ingredients contained in the product formulation is optimized and the final product conforms to The quality uniformity of Kampo preparations. Finally, Tsumura mentioned in his reply, “In the field of botanicals, we are pursuing the highest quality system in the world. PIC/S GMP regulates the management of crude drugs, and we are based on WHO guidelines The standard “Quality Management Practice for Planting and Collection of Medicinal Plants” (GACP) has established an exclusive strict standard for quality management, and the preparation plant has also improved its equipment in accordance with the PIC/S GMP regulations. This modification to shorten the validity period is also one of the links”———–EndThis article was translated from December 21, 2020 A column article in the Japanese Journal of Pharmaceuticals, “Why actively cater to PIC/S regulations? Tsumura’s Quality Management Countermeasures”In order to better understand, the editor adds some information on Tsumura’s official website

  • In the cultivation of crude drugs, extract processing and Japan For domestic processing, Tsumura has established a complete management system

“Raw materials from cultivation and processing to production Process” from the official website of Tsumura

  • Based on GACP to control the source of cultivated crude drugs