3. 4.
5. 6. 7.

System Impact Assessment(SIA)
• VMP+Matrix VMP+表格
SIA SIA
• • •
Systems With indirect Impact and no Impact 间接影响系统和无影响系统 Systems With Impact 有影响系统

Risk Assessment and Regulation

Risk Assessment and Regulation

System Impact Assessment(SIA)
系统影响性评估（SIA）： 评估系统的运行、控制、报警和故障状况对产品质 量的影响的过程。 System Impact Assessment (SIA): The process of evaluating the impact of the operating, controlling, alarming, and failure conditions of a system on the quality of a product. 系统影响性评估将系统分为三类，即直接影响系统、间接影响系统和无影响系 统。 The impact assessment will be classified the system into three categories， such as direct impact system, indirect impact system and no impact system. 在进行影响评估时，将根据7个问题对各设备/系统进行评估。对于任何一个 设备/系统，7个问题中只要有一个问题的答案是“Yes”，就将该设备/系统归类 为直接影响的系统。 Impact of a equipment/system will be assessed according to the following 7 questions. For any equipment/system, if the answer is “yes” to any of the 7 questions, the component is classified as direct impact system.

Critical Component Assessment(CCA) • 通过评估, 部件都归类为关键和非关键两种. According to the assessment, components will be classified as critical or not critical. • 这种归类将根据下列问题进行. The classification is going to be done based on the following questions. • 七个问题中只要有一个问题的答案是“Yes”，就将 该部件归类为关键的部件。 If the answer is “yes” to any of the 7 questions, the component is classified as critical.
是 Yes
间接影响系统 Indirect Impact System
否No
无影响系统 No Impact System
支持判定的依据 Develop supporting Rationale

System Impact Assessment(SIA)
• 案例Case Validation Requirements Form VRF

System Impact Assessment(SIA)
1. 2. Does the system have direct contact with the product or process stream? 系统是否与产品或工艺流直接接触？ Does the system provide an excipient, or does the system produce (or come in direct contact with) an ingredient, raw material or solvent that comes in contact with the process? 系统是否提供一种辅料，或系统是否生产（或直接接触）某种与 工艺接触的成分、原料或溶剂？ Does the system establish or control critical or key process parameters of the manufacturing environment? 系统是否用于建立或控制生产环境中的重要或关键工艺参数？ Is the system a process control system that affects the product’s quality and there is no system for independent verification of control system performance in place? 系统是否是一种能够影响产品质量的工艺控制系统，而且没有可以用于对控制系统 性能进行单独验证的系统？ Is the system used in cleaning or sterilizing operations? 系统是否用于清洁或灭菌操作？ Does the system provide data that is used to determine if a product should be accepted or rejected? 系统是否提供用于判定产品放行的数据？ Does the system preserve product status, such as product quality? 系统是否用于保持产品状态，例如产品质量？

Critical Component Assessment(CCA)
• 洁净HVAC • 洁净压缩空气分配系统 压缩空气分配系统 • 压片机 烘箱 结晶罐
System Impact Assessment SummaryForm 汇总表1,汇总表2 惯例: PW分配系统和制备系统 HVAC系统和空调机组

Critical Component Assessment(CCA) 部件关键性评估(CCA)：通过对“直接影响系统” 的 关键性部件进行风险评估，确定其在整个系统中 的风险程度，并建议控制措施降低其风险。 Component Criticality Assessment: The component criticality assessment is used to assess the risks associated to the critical components of direct impact systems to determine their risk levels in the entire system and to propose control measures to reduce these risks.
●试车计划 ●
Commissioning Schedule
●试车日程表
FAT
SAT
Detailed Technical Specifications, Functional Specifications, PID ●详细技术规范，功能规范，PID
●

System Impact Assessment(SIA)
系统范围界定 Define System Boundaries
系统是否对产品质量有直接 影响？ Does system have direct impact on product quality?
是 Yes
直接影响系统 Direct Impact System
否No
系统是否与直接影响系统 相关联 Is system linked to a Direct Impact System?
FAT
System Impact Assessment(SIA) 系统影响性评估流程 System Impact Assessment Procedure SOP
影响性评估流程 Impact Assessment Process
确定系统 Identify Systems
Direct Impact Systems 直接影响系统
2
• • •
URS and SIA Technical Specification Audit Supplier
• Validation Plan • SIA • Detailed Technical Specification, Functional Specification, PID • DQ Report
风险分析 - 系统影响评估/关键组件分析
马义岭 2010-11-27
Austar Promotes Industry Advancement
Contents内容
• Risk Assessment and Regulation 风险分析及相关法规 • 系统影响评估 System Impact Assessment(SIA) • 关键组件分析CCA Critical Component Assessment(CCA)

Risk Assessment and Regulation
• • • • 欧盟药品质量管理规范—附录20 质量风险管理. EU Guidelines to Good Manufacturing Practice - Annex 20 Quality Risk Management ISPE指南第五卷“调试和验证”. ISPE Baseline guide Volume 5 commissioning and qualification ICH质量风险管理三方协调指导原则Q9，附录1，2 ICH Harmonized Tripartite Guideline Quality Risk Management Q9, Annex I, 2 ASTM E2500-07制药和生物制药生产系统和设备的技术说明、设计 和验证标准指南。 ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.