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CFR为美国联邦法典，21 CFR为其第21章，等同《联邦食品药品化妆品法案》，第11部分为电子签名电子记录，第210 和211部分为制剂CGMP。以下为美国官方GPO电子CFR网址链接：
https://www.ecfr.gov/cgi-bin/text-idx?SID=664058f10d03a00fe41ad9c9ba979da0&mc=true&tpl=/ecfrbrowse/Title21/21cfr211_main_02.tpl
Title 21 → Chapter I→ Subchapter A →Part11
TITLE 21—Food and Drugs食品和药品
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES食品药品管理局，卫生福利部
SUBCHAPTER A—GENERAL通则
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES电子记录，电子签名
Subpart A—GENERALP ROVISIONS 通则
§11.1 Scope.范围 20160527
§11.2 Implementation.实施
§11.3 Definitions.定义
Subpart B—ELECTRONIC RECORDS 电子记录
§11.10 Controls for closed systems. 封闭系统的控制
§11.30 Controls for open systems. 开放系统的控制
§11.50 Signature manifestations. 签名显示
§11.70 Signature/record linking. 签名/记录链接
Subpart C—ELECTRONIC SIGNATURES 电子签名
§11.100 General requirements. 通用要求
§11.200 Electronic signature components and controls.电子签名要素和控制
§11.300 Controls for identification codes/passwords.识别代码/密码控制
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Title 21 → Chapter I→ Subchapter C →Part210
SUBCHAPTER C—DRUGS:GENERAL 药品：通则
PART 210—CURRENT GOOD MANUFACTURING PRACTICE INMANUFACTURING, PROCESSING, PACKING, OR HOLDING OFDRUGS; GENERAL 药品生产、加工、包装和存贮CGMP：通则
§210.1 Status of current good manufacturing practice regulations. CGMP法规的地位 20091210
§210.2 Applicability of current good manufacturing practice regulations. CGMP法规的适用性 20091210
§210.3 Definitions. 定义 20091210
PART 211—Current Good Manufacturing Practice for Finished Pharmaceuticals 制剂CGMP
Subpart A—GENERAL PROVISIONS 通则
§211.1 Scope.范围 20150917
§211.3 Definitions.定义
Subpart B—ORGANIZATION AND PERSONNEL 组织和人员
§211.22 Responsibilities of quality control unit.质量部门职责
§211.25 Personnel qualifications.人员资质
§211.28 Personnel responsibilities.人员职责
§211.34 Consultants.顾问
Subpart C—BUILDINGS AND FACILITIES 建筑和设施
§211.42 Design and construction features.设计和构造特性19950120
§211.44 Lighting.照明
§211.46 Ventilation, air filtration, air heating and cooling.暖通
§211.48 Plumbing. 管件 19830318
§211.50 Sewage and refuse. 污水和废物
§211.52 Washing and toilet facilities.洗浴和盥洗设施
§211.56 Sanitation.卫生
§211.58 Maintenance. 维保
Subpart D—EQUIPMENT 设备
§211.63 Equipment design, size, and location. 设备设计、尺寸和安装位置
§211.65 Equipment construction. 设备结构
§211.67 Equipment cleaning and maintenance.设备清洁和维保 20080908
§211.68 Automatic, mechanical, and electronic equipment.自动、机械和电子设备 20080908
§211.72 Filters.过滤器 20080908
Subpart E—CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES 组份和药品容器密闭器的控制
§211.80 General requirements.通用要求
§211.84 Testing and approval or rejection of components, drug product containers, andclosures. 组份、药品容器密闭系统检测和批准或拒收20080908
§211.86 Useof approved components, drug product containers, and closures. 批准的组份、药品容器密闭器的使用
§211.87 Retesting of approved components, drug product containers, and closures.批准的组份、药品容器密闭器的复测
§211.89 Rejected components, drug product containers, and closures. 拒收的组份、药品容器密闭器
§211.94 Drug product containers and closures. 药品容器密闭器 20161118
Subpart F—PRODUCTION AND PROCESS CONTROLS 生产和工艺控制
§211.100 Written procedures; deviations.书面程序、偏差
§211.101 Charge-in of components. 成分投料 20080908
§211.103 Calculation of yield. 收率计算 20080908
§211.105 Equipment identification. 设备识别
§211.110 Sampling and testing of in-process materials and drug products. 中间体和药品取样和检测20080908
§211.111 Time limitations on production.生产时间限制
§211.113 Control of microbiological contamination.微生物污染控制 20080908
§211.115 Reprocessing. 返工
Subpart G—PACKAGING AND LABELING CONTROL 包装和贴标控制
§211.122 Materials examination and usage criteria.物料检查和使用标准20120320
§211.125 Labeling issuance.标签发放 20161118
§211.130 Packaging and labeling operations. 包装和贴标操作19930803
§211.134 Drug product inspection. 药品检查
§211.137 Expiration dating.有效期19950120
Subpart H—HOLDING AND DISTRIBUTION 存贮和销售
§211.142 Warehousing procedures.仓管程序
§211.150 Distribution procedures.销售程序
Subpart I—LABORATORY CONTROLS 化验室控制
§211.160 General requirements.通则 20080908
§211.165 Testing and release for distribution. 销售检测放行
§211.166 Stability testing. 稳定性试验19811117
§211.167 Special testing requirements.特殊检测要求
§211.170 Reserve samples. 留样19950120
§211.173 Laboratory animals. 实验动物
§211.176 Penicillin contamination. 青霉素污染20160729
Subpart J—RECORDS AND REPORTS 记录和报告
§211.180 General requirements.通则19950120
§211.182 Equipment cleaning and use log.设备清洁和使用日志 20080908
§211.184 Component, drug product container, closure, and labeling records. 部件、药品容器、密闭器和标签记录
§211.186 Master production and control records. 主生产和检测记录
§211.188 Batch production and control records. 批生产和检测记录20080908
§211.192 Production record review. 生产记录审核
§211.194 Laboratory records. 实验室记录20051108
§211.196 Distribution records. 销售记录19840316
§211.198 Complaint files. 投诉文件20030331
Subpart K—RETURNED AND SALVAGED DRUG PRODUCTS 退回和回收药品
§211.204 Returned drug products. 退回药品
§211.208 Drug product salvaging. 药品回收
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Questions and Answers on Specific Topics: FDA对CGMP主题的官网问答
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm124740.htm
Subpart A – General Provisions 通则 2问
Subpart B – Organization and Personnel 组织和人员 暂无
Subpart C – Buildings and Facilities 建筑和设施 10问
Subpart D – Equipment 设备 13问
Subpart E – Control of Components and Drug Product Containers and Closures 部件和药品容器密闭器控制15问
Subpart F – Production and Process Controls 生产和工艺控制 21问
Subpart G – Packaging and Labeling Control 包装和贴标控制暂无
Subpart H – Holding and Distribution 存贮和销售 6问
Subpart I – Laboratory Controls 化验室控制 14问
Subpart J – Records and Reports 记录和报告 4问
Subpart K – Returned and Salvaged Drug Products 退回和回收药品 3问