HACCP工艺风险评估报告模板

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. The

document embraces the principles of ICH Q9 (Quality Risk Management) and uses risk

management 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. This

involved 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