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1、2015/9/7 1 Sound Laboratory Practice and Breaking Down 21 CFR Part 11, Annex 11, and ICH Q7 严谨的实验室操作及联邦法规严谨的实验室操作及联邦法规21章第章第11款款/附录附录11/ICH Q7详解详解 Agenda 概要 History 21 CFR Part 11 EU GMP Annex 11 ICH Q7 Summary 历史 联邦法规21章第11款(21 CFR 11) 欧盟GMP附录11 人用药物注册技术要求国际协调会议Q7 (ICH Q7) 总结 2015/9/7 2 Operating E
2、nvironment 操作环境 Computerised System 计算机化系统 Computer System 计算机系统 Controlled Function or Process 控制功能或流程 Software 软件 SOPs/Staff 标准操作程序/员工 Hardware 硬件 Equipment 设备 What are we talking about? 我们要讨论什么? 21 CFR Part 11 联邦法规21章第11款 1991 1992 1994 1997 2003 History 历史 2015/9/7 3 1991 1992 2006 2011 EU GMP A
3、nnex 11 欧盟GMP附录11 History 历史 21CFR FDA, Code of Federal Regulations 21CFR58 GLP 21CFR210 GMP, Drugs (General) 21CFR211 GMP, Drugs (Finished Pharmaceuticals) 21CFR312 Inv. New drug Application (GCP) 21CFR314 FDA Approval of new drug (GCP) 21CFR600, 601, 610 GMP, biologics 21CFR820 GMP, Devices 21CFR
4、Food, nutrients and cosmetics 21CFR11 Electronic Records; Electronic Signatures 21CFR FDA(美国食品药品监督管理局), 联邦法规 21CFR58 GLP(药物非临床研究管理规范) 21CFR210 GMP(药品生产质量管理规范),药物(总则) 21CFR211 GMP,药物(成品制剂) 21CFR312 试验用新药申请(药物临床试验质量管理规范) 21CFR314 FDA 批准上市的新药(药物临床试验质量管理规范) 21CFR600, 601, 610 GMP,生物制品 21CFR820 GMP,医疗器械
5、21CFR 食品、营养品及化妆品 21CFR11 电子记录;电子签名电子记录;电子签名 What is 21 CFR 11 什么是21 CFR 11(联邦法规21章第11款)? 2015/9/7 4 21 CFR 11 at one Glance 21 CFR 11总览 Electronic records equivalent with paper records Storage, retrieval and copying in full retention period Submitting to FDA Protection of electronic records Security
6、 (physical and logical) Validation Audit trail (who did what, when including reason where req.) Permission to use of electronic signature Equivalent with handwritten signatures Name, date and meaning Linking of signature to record Unique for an individual 电子记录与纸质记录具有同等效力 整个保管期内记录的保存、检索及复制 提交至FDA 电子记
7、录的保护 安全(物理安全和逻辑安全) 验证 审查跟踪(执行者、所做工作、时间、原因以及地点) 允许使用电子签名 与手写签名具有同等效力 名字、日期及含义 签名与记录之间的联系 个人签名必须是唯一的 21 CFR 11 Core Topics 21 CFR 11核心主题 2015/9/7 5 Applies to electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally
8、 equivalent to paper records and handwritten signatures executed on paper Applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted (including regulatory submissions) Applies to Computer systems (including hardware and software), controls, and
9、attendant documentation maintained 适用于电子记录、电子签名以及电子记录上的手写签名,要求其真实可信,通常与在纸质文件上的纸质记录和手写 签名具有同等效力 适用于以电子表格形式创建、修改、保存、归档、检索或发送(包括向管理机构递交)的记录 适用于计算机系统(包括硬件和软件)、系统控制及保存的随附文件 21 CFR Part 11 Scope (extract) 21 CFR 11的管理范围(摘录) Closed system means an environment in which system access is controlled by persons
10、 who are responsible for the content of electronic records that are on the system. Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the inte
11、grity of the data can be verified Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individuals handwritten signature. Electronic record means any combination of text
12、, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system 封闭系统指一种环境,在此环境中系统访问受控于管理系统中电子记录内容的负责人。 数字签名是指一种基于对发件人的身份验证进行加密处理的电子签名,使用一套规则和一系列参数进行计算以便对 签名者的身份和数据的完整性进行校验。 电子签名是指一
13、种与某人的手写签名具有同等法律效力的,由其使用、采用或授权使用的任何符号或一系列符号组 成的计算机数据编译。 电子记录是指任何以电子格式呈现的文本、图表、数据、声音资料、图像资料或其它信息的总称,它的建立、修改、 维护、归档、检索或分发是由计算机系统来完成的。 21 CFR Part 11 Definitions (selection) 21 CFR 11定义(摘选) 2015/9/7 6 21 CFR11 Controls for Closed Systems (examples) 21 CFR 11封闭系封闭系 统的控制(举例)统的控制(举例) Validation 验证 Revision
14、/C hange Control 修订/修改 控制 Protection of Records 记录保护 Access Limitations 访问限制 Audit Trails 审计跟踪 Control of Sequence 顺序控制 Source of Data Inputs 数据输入源 21CFR11 Electronic Signatures (selection) 21 CFR 11 电子签名( 选摘) Loss Management 丢失管理 Prevent unauthorised use 避免未经授权使用 ID & Password 用户名&密码 Regular testin
15、g of Devices (tokens, card etc.) 设备常规检测(电 子令牌、电子卡片等) Uniqueness 独特性 Periodic change of ID/ password 定期更换用户名/ 密码 2015/9/7 7 Approach covered by 21CFR11 ? 哪些方法符合21 CFR 11要求? Guidance for Industry 行业指南 2015/9/7 8 GfI: 21 CFR Part 11 行业指南:21 CFR 11 GfI: 21 CFR Part 11 行业指南:21 CFR 11 2015/9/7 9 Highlights of the Revision in 2011: Formal agreements with 3rd Parties Introduction of Risk Assessment Audit trails to be shown to inspectors Need for Audit Trails for critical records, regular review Investigations of all incidents Electronic Signatures