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1、Risk Assessment Report for XXX Process XXX工艺风险评估报告Report Approval报告批准Company/Title公司/职务Name姓名Signature签名Date日期Written by编写Reviewed by审核Approved by批准Revision History 版本修订索引Rev.版本Date 日期Revision Reasons 修订原因002011/10/30Initial issuance 新制订Index 目录1Overview概述42Purpose 目的43Scope范围44Responsibility 职责45Ab
2、breviations缩略语66Regulation and Guidance 法规和指南77System Description系统描述97.1Plant Description车间概述97.2Product Information产品信息107.3Equipments/System List设备/系统清单158Reference Documents 参考文件169Risk Assessment Method 风险评估方法179.1Conduct a Hazard Analysis进行危害分析179.2Determine the Critical Control points (CCPs)关
3、键控制点的确认209.3Establish Target Levels and Critical Limits建立目标水平和关键限值219.4Establish System(s) to monitoring CCP 建立CCP监测系统219.5Establish an appropriate Corrective Action Plan建立适当的纠正计划229.6Establish Procedures建立规程229.7Establish Documentation and keep records建立文件并保留记录2310Hazard analysis Matrix危害分析矩阵2511CC
4、P Control Matrix关键控制点控制矩阵2612Conclusion结论&建议271Overview 概述This document summarizes the quality risk management report for XXX at the XXX site. The document embraces the principles of ICH Q9 (Quality Risk Management) and uses risk management tools to support manufacturing strategies designed to minim
5、ize 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. This involved a holistic assessment that identified the potential hazards and risks to product qua
6、lity 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
7、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。2Purpose 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 XXXby applying the principle o
8、f 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
9、 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。3Scope 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。4Responsibilit
10、y 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
11、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
12、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
13、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
14、风险评估Review and approve the report报告的审核和批准5Abbreviations 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。Abbreviations缩略语Definition定义CCPCritical Control Points关键控制点EUEuropean Union欧洲联盟GMPGood Manufacturing Practice药品生产质量管理规范HACCPHazard Analysis and Critical Control Point危害分析与关键控制点ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药品注册技术要求国际协调会ISPEInternational Society for Productivity Enhancement国际制药工程协会PQPerformance Qualification性能确认PVProcess Validatio
