业务连续性和灾难恢复计划规程Business Continuity and Disaster Recovery Plan1 目的/Purpose本规程规定系统发生不同程度中断时需要维持安全的业务连续性所需要准备的业务连续性和灾难恢复计划。
This document is to define the procedures on preparing a business continuity and disaster recovery plan to allow for the safe continuance of business in the event of disruption of various multitudes.2 范围/Scope2.1 所有GMP计算机系统All GMP computerized system3 职责/Responsibilities3.1 系统用户System User参与编写业务连续性和灾难恢复计划Co-author business continuity and disaster recovery plan3.2 部门/车间负责人Head of Department/Workshopa) 审核业务连续性和灾难恢复计划Review of the business continuity and disaster recovery planb) 实施业务连续性和灾难恢复计划Execution of the business continuity and disaster recovery plan3.3 验证Validationa) 审核业务连续性和灾难恢复计划Review of business continuity and disaster recovery planb) 对发生的系统中断进行质量影响评估Perform quality impact assessment in the event of system disruption3.4 技术管理员Technical Administratora) 编写业务连续性和灾难恢复计划Author business continuity and disaster recovery planb) 审核业务连续性和灾难恢复计划Review of business continuity and disaster recovery planc) 实施业务连续性和灾难恢复计划Execution of business continuity and disaster recovery plan3.5 质量管理部QM Departmenta) 审核业务连续性和灾难恢复计划Review of the business continuity and disaster recovery planb) 实施业务连续性和灾难恢复计划Execution of business continuity and disaster recovery plan3.6 质量负责人Head of Qualitya) 批准业务连续性和灾难恢复计划Approval of business continuity and disaster recovery planb) 批准调用业务连续性和灾难恢复计划Approval of invoking business continuity and disaster recovery plan4 定义Definition业务连续性管理：涵盖系统中断后需要恢复业务同时继续为客户/用户提供产品和服务的步骤。
Business continuity management: Encompasses the steps required to restore business processes following a disruption while continuing to provide product or services to the customer/user.业务连续性计划：涵盖保证连续性的为客户/用户提供产品和服务的规程或工艺并且是业务连续性管理的一部分。
Business continuity plan: Covers the procedures/processes required to ensure the continuance provision of product or services to the customer/user and is part of business continuity management.灾难恢复计划：涵盖针对系统的技术恢复并且是业务连续性管理的一部分。
Disaster recovery plan: covers the technical recovery of a specific system and is a part of business continuity management.CAPA：纠正预防措施Corrective Action Preventive ActionGMP：药品生产管理规范Good Manufacturing PracticeSOP：标准操作规程Standard Operating Procedure5 程序/Procedure5.1 重大业务中断Significant business disruption5.1.1 影响工厂运行和通讯不超过三小时的内部重大业务中断。
此类中断不仅限于通讯和公用系统的中断。
Internal significant business disruption that affects the operation and communication within the plant for not more than 3 hours, it may include but not limited to loss of communication or utilities.5.1.2 影响工厂运行和通讯超过三小时的内部重大业务中断并不仅限于：Internal significant business disruption that affects the operation and communication within the plant for more than 3 hours and includes but not limited to:5.1.2.1 不同程度的系统故障或瘫痪，如服务器瘫痪Multitude of system failure or breakdown i.e. server breakdown5.1.2.2 系统安全受到破坏Breach of security5.1.3 外部重大业务中断指的是导致工厂所在的整个区域的运行和通讯中断并不仅限于：External significant business disruption refers to disruption that cripples the operation and communication of the entire area where the plant is located and includes but not limited to:5.1.3.1 恐怖分子袭击Terrorist attack5.1.3.2 自然灾害如地震Natural disaster i.e. earthquake.5.1.3.3 大规模的区域中断如洪水泛滥Wide scale, regional disruption i.e. flood.5.2 除了5.1.1描述的中断，一旦发现任何5.1.2和5.1.3描述的中断即直接实施业务连续性管理。
Except for disruptions described in 5.1.1, proceed to business continuity management upon observation of any disruptions described in 5.1.2 and 5.1.3.5.3 5.1.1描述的中断按照《计算机系统问题报告管理规程》处理。
Disruptions described in 5.1.1 will be managed in accordance with “User Problem Reporting Management for Computerized System”5.4 业务连续性管理Business continuity management5.4.1 用户问题报告User problem reporting5.4.1.1 发生内部重大中断时必须及时按照《计算机系统问题报告管理规程》填写用户问题报告。
Prepare user problem report in accordance with “User Problem Reporting Management for Computerized System” instantly in the event of the occurrence of internal significant disruption.5.4.1.2 验证组长根据《质量风险管理规程》进行中断评估并判断是否宣告灾难并调用业务连续性和灾难恢复计划。
Validation supervisor will perform assessment in accordance with “Quality Risk Management” to determine the necessity of declaring a disaster, and invoking the business continuity and disaster recovery plan5.4.1.3 评估期间如果发现中断涉及GMP影响如产品质量受损或GMP数据丢失即按照《偏差管理规程》填写偏差报告。
Raise a deviation in accordance with “Deviation Management” if the disruption has GMP impact e.g. product quality is affected or there is loss of GMP data during the course of assessment.5.4.1.4 如果编写偏差报告，中断的调查和纠正预防措施将按照偏差管理系统进行。