Risk Assessment Report for XXX Process XXX工艺风险评估报告Revision History版本修订索引Index 目录1Overview概述 (4)2Purpose 目的 (4)3Scope范围 (4)4Responsibility 职责 (4)5Abbreviations缩略语 (6)6Regulation and Guidance 法规和指南 (7)7System Description系统描述 (9)7.1Plant Description车间概述 (9)7.2Product Information产品信息 (10)7.3Equipments/System List设备/系统清单 (15)8Reference Documents 参考文件 (16)9Risk Assessment Method 风险评估方法 (17)9.1Conduct a Hazard Analysis进行危害分析 (17)9.2Determine the Critical Control points (CCPs)关键控制点的确认 (20)9.3Establish Target Levels and Critical Limits建立目标水平和关键限值 (21)9.4Establish System(s) to monitoring CCP 建立CCP监测系统 (21)9.5Establish an appropriate Corrective Action Plan建立适当的纠正计划 (22)9.6Establish Procedures建立规程 (22)9.7Establish Documentation and keep records建立文件并保留记录 (23)10Hazard analysis Matrix危害分析矩阵 (25)11CCP Control Matrix关键控制点控制矩阵 (26)12Conclusion结论&建议 (27)1 Overview概述This document summarizes the quality risk management report for XXX at the XXX site. Thedocument embraces the principles of ICH Q9 (Quality Risk Management) and uses riskmanagement tools to support manufacturing strategies designed to minimize risks to product quality.本文件总结了位于XXX 的XXX的质量风险管理报告。
本文件包括ICH Q9（质量风险管理）的原则以及使用合适的风险管理工具来支持设计用于将对产品质量的风险降到最低的生产策略。
A formalized risk management approach was applied to the XXX manufacturing facility. Thisinvolved a holistic assessment that identified the potential hazards and risks to product quality for all products handled in the facility to ensure that appropriate controls were in place to manufacture these products safely. The assessment supported the development of a quality risk management (QRM) that addressed the manufacture of the following products: XXX.对XXXXX生产工厂采用了一种正式化的风险管理方法。
这涉及到能够确定对产品质量的可能危害和风险的全瞻性评估，以保证具有适宜的控制来以安全的方式生产这些产品。
这种评估行为针对XXXX 产品生产的质量风险管理（QRM）的制定提供了支持。
2 Purpose 目的The purpose of this process risk assessment is to evaluate, define, and document all potential hazard and critical control points for XXX Process of Oral Dosage Plant of XXX by applying the principle of ICH Q9 (Quality Risk Management) and risk management tool of Hazard Analysis and Critical Control Point (HACCP). This assessment activity is to ensure that the products can be manufactured under appropriate control and safety method, and provide support to define process critical control points of XXX Process.本工艺风险评估的目的是应用ICH Q9（质量风险管理）的原则以及使用危害分析和关键控制点（HACCP）的风险管理工具评估确定出XXX车间XXX生产工艺中所有的潜在危险和关键控制点，并记录在文件中。
以保证具有适宜的控制，并以安全的方式生产该产品。
这种评估行为针对XXX的生产工艺关键控制点的制定提供了支持。
3 Scope范围The risk assessment scope is the XXXX in XXX Plant of XXXX. The Product Code: XXX.本工艺风险评估的范围为XXXX车间XXX，产品代码为XXX。
4 Responsibility 职责XXX responsibility XXX的职责：✓Risk assessment execution进行风险评估✓Risk Assessment Report compilation风险评估报告的编写XXX responsibility XXX的职责：To assure that product-specific knowledge and expertise are available for the development of an effective HACCP plan by assembling a multidisciplinary team. Team members should represent all the relevant disciplines, such as research and development, production, quality control, quality assurance, microbiology, engineering and distribution or others as applicable with the ability to:确保具有产品的详细知识和专业技术，用以各专业组开发有效地危害分析和关键工艺控制点的计划。
小组成员应代表研发，生产，质量控制，质量保证，微生物学，工程和发货以及其他相关领域能力。
✓Conduct a hazard analysis实施危害分析✓Identify potential hazards识别潜在的危害✓Identify hazards which should be controlled识别应该控制的危害✓Recommend controls and critical limits建议的控制和关键限度✓Devise procedures for monitoring and verification监测和确认的设计程序✓Recommend appropriate corrective action where deviations occur对发生的偏差推荐合适的纠正措施✓Establish Documentation and keep records建立文件并保留记录✓Verify the HACCP plan确认危害分析和关键控制点计划Other responsibilities:其它职责✓Information collection信息的收集✓Supply all procedure, data, manuals, drawing and documentation necessary for the completion of final report提供为报告编写所需要的所有的规程、数据、手册、图纸和文件✓Taking part in the RA参与风险评估✓Review and approve the report报告的审核和批准5 Abbreviations缩略语The abbreviations which will be used in this document are listed in the following form.在下面的表格中规定了本文件中使用的缩略语。
6 Regulation and Guidance 法规和指南To write this protocol the following reference documents have been used:为了编写本报告，参考了以下法规和指南：✓State Food and Drug Administration (CFDA), China, Good Manufacturing Practice (2010 Revision), March, 2011国家食品药品监督管理局（CFDA），中国，药品生产质量管理规范（2010年修订），2011年03月✓ICH Q9: Quality Risk ManagementICH Q9：质量风险管理，2005年11月✓ISPE Guideline Volume 5, Commissioning and Qualification, 1st Edition, 2001 ISPE指南5“调试和确认”，2001年第一版✓ISPE Guideline Volume 7, Risk Based Manufacture of Pharmaceutical Products, 1st Edition, 2010ISPE指南7“基于风险分析的制药产品生产”，2010年第一版✓ISPE Good Practice Guides for Applied Risk Management for Commissioning and Qualification,1st Edition, 2011ISPE良好实践指南，基于风险分析的调试和确认，2011年第一版✓ISPE GAMP 5 (Good Automated Manufacturing Practice 5)ISPE GAMP 5良好的自动化制造规范,2008年第五版✓ISPE Pharmaceutical Engineering Guides for New and Renovated facilities, Volume 4: Water and steam systemsISPE 新建和改造的工厂医药工程指南，第4卷-水和蒸汽系统✓WHO Technical Report series No. 908, 2003, Annex 7 WHO 技术报告系列No. 908，2003，附录77 System Description系统描述7.1 Plant Description车间概述7.2 Product Information产品信息7.2.1Product Name产品名称：General Name: XXX通用名称：XXXEnglish Name: XXX英文名称：XXXPinyin: XXX汉语拼音：XXXDosage: XXX剂型：XXX7.2.2 Description描述：Activity ingredients of this product is XXX.本品主要成份为XXX。