FDA 21 CFR Part 11 Electronic Code of Federal Regulations Title 21: Food and Drugs Part 11—Electronic Records; Electronic Signatures e-CFR data is current as of February 23, 2017 Contents Subpart A—General Provisions § 11.1 Scope. § 11.2 Implementation. § 11.3 Definitions. Subpart B—El...
FDA水产品HACCP 法规 21 CFR 123, 1240FDA水产品HACCP 法规 21 CFR 123, 11FDA水产品HACCP 法规Subpart ADefinitions 定义Good Manufacturing Prac
从21CFR Part11的目录看整个法规分为3章,分别是: TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A - GENERAL PART11 ELECTRONIC RECORDS;ELECTRONIC SIGNATURES Subpart A - General Provisions§ 11.1 - Scope. (a) The regulations in ...
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B): 现行生产质量管理规范(21 CFR第117部分,B部分): 2. You did not store or transport food, including ingredients, under conditions that protect against allergen cross-contact to comply with 21 CFR 117.93. Specifically, on March ...
9见2013年1月22日发布的最终规则”组合产品的现行良好生产规范要求“(21CFRPart4,SubpanA:78FR4307-22) 和2016年12月20日发布的最终规则“组合产品的上市后安全报告”(21CFRPart4.Subpar【B:81FR92603-26)。 1同上。 3 包含所含建议不具约束力建议 ...
Type B (EOP) Meeting 116 117 Type B (EOP) meetings are as follows: 118 119 Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing 120 approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar 121 products) ...
Provides the text of U.S. FDA 21 CFR Part 820 as an example of configuration management in a regulatory environment
Importance. Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the
the requirements of 21 CFR part 1 subpart L for the food products you import, including, but not limited to, your Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese, all imported from your foreign supplier(b)(...
Subpart B - Electronic Records § 11.10 - Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electroni...