REQUIREMENTS 328 含有酒精的预期用于口部摄入的非处方药品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL 一般认为安全与有效以及不错误标识的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 用于非...
Title 21 CFR Part 11, an FDA compliance guideline, specifies the standards for evaluating the trustworthiness of electronic records and electronic signatures.
807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 人用体外诊断产品 IN VITRO...
1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的...
1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式 ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I...
Part 820– Quality System Regulation: Describes the requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. ...
21 CFR Part 11 insight: Solutions to keep your thermal analysis work in line with FDA requirementsMETTLER TOLEDO
What are 21 CFR part 11 requirements? There are various requirements necessary to be compliant with 21 CFR part 11. This includes the generation of accurate and complete copies of signed records in both human-readable and electronic form, availability of records during the retention period, access...
In addition to Good Manufacturing Practices, supply chain oversight, labeling, registrations, listings, adverse event tracking and all the other regulatory requirements required by FDA, use of electronic records and submissions adds an additional compliance requirement – 21 CFR 11 except for recor...
美国FDA《联邦规章典集》(CFR)第21篇目录中文版 发布时间:2010-5-1113:44:12发布方:奥咨达医疗器械咨询 美国《联邦规章典集》(CFR)第21篇“食品与药品”总目 概述:美国《联邦规章典集》(CodeofFederalRegulations,CFR)第21篇“食品与药品(”Title21―FoodandDrugs)共有9卷(Volume)、 3章(Chapter)、1499部(P...