{"title":"[注册合格评定机构的角色和运作]。","authors":"Takayuki Asakura","doi":"10.1248/yakushi.24-00164-3","DOIUrl":null,"url":null,"abstract":"<p><p>As of August 2023, 99 organizations were registered as conformity assessment bodies by the Ministry of Health, Labour, and Welfare in accordance with Article 33 of the Food Sanitation Act. These registered organizations are authorized to conduct inspections of imported food as well as domestic expropriation inspections. In recent years, we have actively participated in a project to develop new test methods, aiming to enhance our contribution as a registered testing organization and to maintain food hygiene by widely applying these developed methods. There is a need to develop new test methods for pesticides and veterinary medicines used in Japan, as well as for several drugs used internationally. Previously, gas chromatography and high-performance liquid chromatography were the standard methods, and only parent compounds were analyzed. Recently, the demand for test methods applicable not only to agricultural products but also to livestock and marine foods has increased, necessitating the analysis of metabolites in addition to parent compounds. Although developing analytical methods to detect certain metabolites has been challenging, advancements in the variety of separation and pretreatment columns, along with the widespread use of LC-MS/MS and GC-MS/MS techniques, have enabled the development of test methods for many compounds. In this study, we introduce a method to solve the challenges and problems associated with test method development.</p>","PeriodicalId":23810,"journal":{"name":"Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan","volume":"145 2","pages":"105-108"},"PeriodicalIF":0.3000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[The Roles and Operations of Registered Conformity Assessment Body].\",\"authors\":\"Takayuki Asakura\",\"doi\":\"10.1248/yakushi.24-00164-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>As of August 2023, 99 organizations were registered as conformity assessment bodies by the Ministry of Health, Labour, and Welfare in accordance with Article 33 of the Food Sanitation Act. These registered organizations are authorized to conduct inspections of imported food as well as domestic expropriation inspections. In recent years, we have actively participated in a project to develop new test methods, aiming to enhance our contribution as a registered testing organization and to maintain food hygiene by widely applying these developed methods. There is a need to develop new test methods for pesticides and veterinary medicines used in Japan, as well as for several drugs used internationally. Previously, gas chromatography and high-performance liquid chromatography were the standard methods, and only parent compounds were analyzed. Recently, the demand for test methods applicable not only to agricultural products but also to livestock and marine foods has increased, necessitating the analysis of metabolites in addition to parent compounds. Although developing analytical methods to detect certain metabolites has been challenging, advancements in the variety of separation and pretreatment columns, along with the widespread use of LC-MS/MS and GC-MS/MS techniques, have enabled the development of test methods for many compounds. In this study, we introduce a method to solve the challenges and problems associated with test method development.</p>\",\"PeriodicalId\":23810,\"journal\":{\"name\":\"Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan\",\"volume\":\"145 2\",\"pages\":\"105-108\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1248/yakushi.24-00164-3\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1248/yakushi.24-00164-3","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
[The Roles and Operations of Registered Conformity Assessment Body].
As of August 2023, 99 organizations were registered as conformity assessment bodies by the Ministry of Health, Labour, and Welfare in accordance with Article 33 of the Food Sanitation Act. These registered organizations are authorized to conduct inspections of imported food as well as domestic expropriation inspections. In recent years, we have actively participated in a project to develop new test methods, aiming to enhance our contribution as a registered testing organization and to maintain food hygiene by widely applying these developed methods. There is a need to develop new test methods for pesticides and veterinary medicines used in Japan, as well as for several drugs used internationally. Previously, gas chromatography and high-performance liquid chromatography were the standard methods, and only parent compounds were analyzed. Recently, the demand for test methods applicable not only to agricultural products but also to livestock and marine foods has increased, necessitating the analysis of metabolites in addition to parent compounds. Although developing analytical methods to detect certain metabolites has been challenging, advancements in the variety of separation and pretreatment columns, along with the widespread use of LC-MS/MS and GC-MS/MS techniques, have enabled the development of test methods for many compounds. In this study, we introduce a method to solve the challenges and problems associated with test method development.