{"title":"用于药品工业生产的工艺、设备和系统的验证活动","authors":"Igor Valerievich Korobkin","doi":"10.33920/med-13-2204-07","DOIUrl":null,"url":null,"abstract":"The quality of the finished product must be laid down before the production process. It seems relevant to create guarantees that the finished medicinal product not only meets regulatory conditions, but is also manufactured in accordance with the same procedure and under the same conditions every time it is released. Validation, as a section of the GMP rules, describes the control of a given process.","PeriodicalId":12259,"journal":{"name":"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)","volume":"45 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Activities for the validation of processes, qualification of equipment and systems used in the industrial manufacture of medicines\",\"authors\":\"Igor Valerievich Korobkin\",\"doi\":\"10.33920/med-13-2204-07\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The quality of the finished product must be laid down before the production process. It seems relevant to create guarantees that the finished medicinal product not only meets regulatory conditions, but is also manufactured in accordance with the same procedure and under the same conditions every time it is released. Validation, as a section of the GMP rules, describes the control of a given process.\",\"PeriodicalId\":12259,\"journal\":{\"name\":\"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)\",\"volume\":\"45 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-03-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33920/med-13-2204-07\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33920/med-13-2204-07","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Activities for the validation of processes, qualification of equipment and systems used in the industrial manufacture of medicines
The quality of the finished product must be laid down before the production process. It seems relevant to create guarantees that the finished medicinal product not only meets regulatory conditions, but is also manufactured in accordance with the same procedure and under the same conditions every time it is released. Validation, as a section of the GMP rules, describes the control of a given process.