{"title":"国际药物控制委员会2017年报告","authors":"Виталий А. Орлов","doi":"10.18356/9789213631447","DOIUrl":null,"url":null,"abstract":"The matter presents the analysis of results for GMP inspections of foreign manufacturing sites in 2017 and gives the comparison of them with the results from 2016. Statistical evaluation of the results obtained is also given. In comparison with the corresponding results from 2016, there is a significant increase in the total number of inspections conducted. The changes also reflected in the percentage of discovered GMP non-conformities both in terms of criticality and in the categories of good manufacturing practices. The article also presents some examples of discovered GMP non-conformities.","PeriodicalId":178219,"journal":{"name":"Doklad Mezdunarodnogo komiteta po kontrolû nad narkotikami","volume":"24 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Доклад Международного комитета по контролю над наркотиками за 2017 год\",\"authors\":\"Виталий А. Орлов\",\"doi\":\"10.18356/9789213631447\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The matter presents the analysis of results for GMP inspections of foreign manufacturing sites in 2017 and gives the comparison of them with the results from 2016. Statistical evaluation of the results obtained is also given. In comparison with the corresponding results from 2016, there is a significant increase in the total number of inspections conducted. The changes also reflected in the percentage of discovered GMP non-conformities both in terms of criticality and in the categories of good manufacturing practices. The article also presents some examples of discovered GMP non-conformities.\",\"PeriodicalId\":178219,\"journal\":{\"name\":\"Doklad Mezdunarodnogo komiteta po kontrolû nad narkotikami\",\"volume\":\"24 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1900-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Doklad Mezdunarodnogo komiteta po kontrolû nad narkotikami\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18356/9789213631447\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Doklad Mezdunarodnogo komiteta po kontrolû nad narkotikami","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18356/9789213631447","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Доклад Международного комитета по контролю над наркотиками за 2017 год
The matter presents the analysis of results for GMP inspections of foreign manufacturing sites in 2017 and gives the comparison of them with the results from 2016. Statistical evaluation of the results obtained is also given. In comparison with the corresponding results from 2016, there is a significant increase in the total number of inspections conducted. The changes also reflected in the percentage of discovered GMP non-conformities both in terms of criticality and in the categories of good manufacturing practices. The article also presents some examples of discovered GMP non-conformities.
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