美国FDA违反CAPA的警告信:回顾

Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola, S. G. Vasantharaju
{"title":"美国FDA违反CAPA的警告信:回顾","authors":"Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola, S. G. Vasantharaju","doi":"10.2174/2213476x06666191015114427","DOIUrl":null,"url":null,"abstract":"\n\nUnited States Food and Drug Administration (USFDA) is a federal agency functioning\nunder United States Federal Executive Departments, which strives to regulate the food products\nand drug substances being manufactured or brought into US market, upholding Quality and Safety\nas prime goals. It takes care of its goals by inspecting firms which market products in the United\nStates. It chalks out good manufacturing procedures for obtaining quality end-products. Based on\ninspections conducted and data collected thereby, those not abiding by rules shall be issued with\nWarning Letters and marketing license shall be cancelled for those who fail to justify the warning\nletter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to\nbe achieved to survive in market.\n","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"92 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2020-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"US FDA Warning Letters of CAPA Violations: A Review\",\"authors\":\"Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola, S. G. Vasantharaju\",\"doi\":\"10.2174/2213476x06666191015114427\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n\\nUnited States Food and Drug Administration (USFDA) is a federal agency functioning\\nunder United States Federal Executive Departments, which strives to regulate the food products\\nand drug substances being manufactured or brought into US market, upholding Quality and Safety\\nas prime goals. It takes care of its goals by inspecting firms which market products in the United\\nStates. It chalks out good manufacturing procedures for obtaining quality end-products. Based on\\ninspections conducted and data collected thereby, those not abiding by rules shall be issued with\\nWarning Letters and marketing license shall be cancelled for those who fail to justify the warning\\nletter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to\\nbe achieved to survive in market.\\n\",\"PeriodicalId\":8525,\"journal\":{\"name\":\"Applied Clinical Research, Clinical Trials and Regulatory Affairs\",\"volume\":\"92 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-07-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Applied Clinical Research, Clinical Trials and Regulatory Affairs\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/2213476x06666191015114427\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/2213476x06666191015114427","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

美国食品和药物管理局(USFDA)是美国联邦行政部门下属的联邦机构,致力于监管正在生产或进入美国市场的食品和药品,坚持质量和安全作为首要目标。它通过检查在美国销售产品的公司来实现自己的目标。它为获得高质量的最终产品制定了良好的生产程序。根据检查结果和收集到的数据,对不遵守规定的,给予警告信,对警告信不成立的,取消上市许可。这在制造商之间带来了纪律,并设定了在市场中生存所需实现的质量目标。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
US FDA Warning Letters of CAPA Violations: A Review
United States Food and Drug Administration (USFDA) is a federal agency functioning under United States Federal Executive Departments, which strives to regulate the food products and drug substances being manufactured or brought into US market, upholding Quality and Safety as prime goals. It takes care of its goals by inspecting firms which market products in the United States. It chalks out good manufacturing procedures for obtaining quality end-products. Based on inspections conducted and data collected thereby, those not abiding by rules shall be issued with Warning Letters and marketing license shall be cancelled for those who fail to justify the warning letter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to be achieved to survive in market.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信