PDA TR44_无菌过程质量风险管理(中英文).docx

《PDA TR44_无菌过程质量风险管理(中英文).docx》由会员分享，可在线阅读，更多相关《PDA TR44_无菌过程质量风险管理(中英文).docx（63页珍藏版）》请在第一文库网上搜索。

1、PO隆就盟y翻遹矗游j磁的iTechnical report No.44第44号技术报告Quality risk management for aseptic processes无菌工艺质量风险管理2008 supplement volume 62 N0.S-12008年增补版第62卷第S-1号Quality Risk Management for Aseptic Processes无菌工艺质量风险管理Technical Report No. 44 Supplement to the第44号技术报告朴克PDA Journal of Pharmaceutical Science and Tech

2、nology注射用药物协会制药科学与技术杂志Vol 62,NoS-l第62卷，第S-I号2008年PDAParcntcral Drug Association1.0 Introduction4绪论41.1. PurposeZScope5目的/范围62.0 Glossary of Terms8专业术语词汇表83.0 Aseptic Processing and Quality Risk Management13无菌工艺与质量风险管理133.1. Risk Management Benefits14风险管理益处143.2. Risk Management Considerations15风险管理考

3、虑153.3. Risk Management Program16风险管理程序164.0 AsepticProcessing QuaIityRiskManagementModeI25无菌工艺质量风险管理模式254.1. FMEA Model Overview25失效模式影响分析模式综述254.2. FMEA Model Examples33失效模式与影响分析模式示例335.0 Conclusion56给论566.0 Appendix58附录586.1. Risk Assessment of Aseptic Filling - ExampIeThree58无菌灌装风险评估一示例3586.2. R

4、isk Assessment of Autoclave Failure - Example Four62灭菌釜失效风险评估一示例4627.0 Reference64建议阅读648.0 Suggested reading651.0 Introduction绪论Risk management has been applied to numerous endeavors in a broad range of industries including the development of military strategies, pioneering space discovery and auto

5、motive design. A risk management program facilitates the identification of areas of criticality or vulnerability, determines the appropriate application of risk controls and helps to communicate those risks to appropriate organization decision makers. Quality risk management is an important part of

6、science-based decision making which is essential for quality management of pharmaceutical manufacturing.风险管理已经在各种工业领域广泛应用，包括军事战略开发，尖端空间探索以及汽车设 计。风险管理程序利于对某些方面的危险程度或是其薄弱环节的辨识，确定风险控制恰 当应用，并有助于对恰当的组织决策者进行这些风险的沟通。质量风险管理是基于科学 决策的一个重要部分，其是药品制造质量管理必要部分.Pharmaceutical manufacturers have made risk-based deci

7、sions for many years. However, a more formal approach to risk management was embraced in 2002 with the FDA,s unveiling of Pharmaceutical cGMP,s for the 21st Century: A Risk-Based Approach. This draft report paved the way for a structured, science-based quality risk management approach to ensure indu

8、stry and regulatory focus on critical operations for patient safety. The final report was issued in September 2004 with additional guidance documents that further outlined FDAs support of quality risk management techniques to ensure product quality and facilitate continuous improvement.制药行业以风险为基础来做出

9、决策已经有很多年了，但是风险管理的正式方法是在2002 年随着FDA将“21世纪药品CGMP:基于风险的办法”公诸于众而被引入的。这份草拟报 告为结构化，科学化的质量风险管理方法铺平了道路，以确保行业及药监部门将重点放 在患者安全的关键操作上。2004年九月发行的附加指南最终报告文件，进一步阐述了 FDA对质量风险管理技术的支持以确保产品质量并促使其持续改进。This technical report introduces the basic concepts of quality risk management and includes a model chat may be used as

10、 a tool for conducting a risk assessment. Aseptic processing has been selected as the focus because it contains inherent risks due to consequences of process failure and challenges in the detection, control and management of product contamination. More detailed information on establishing a quality

11、risk management program for aseptic processing is then provided. This is followed by examples of hypothetical risk assessments designed to illustrate the use of the model. The examples are not designed as a commentary or a guide for aseptic processing practices. The report includes a glossary of ter

12、ms and concludes with additional examples showing flexibility of the model, references and a bibliography.本技术报告介绍了质量风险管理的基本概念，并且包含了一种可作为风险评估工具的模 式。由于无菌操作本身就存在着风险，其工艺步骤容易产生故障，污染情况的探测、控 制和管理等方面存在着挑战性，对产品，所以无菌操作被定为风险管理关注的焦点。继 而提供了建立无菌工艺质量风险管理的详细资料。接下来是一个假设风险评估设计的例 子，以说明如何使用这个模式。例子并不作为对无菌工艺实际操作的评论及指南。本报

13、 告还包含专业术语词汇表，以及额外的例子，来说明模式的灵活性，供引用和参考。Approaches for quality risk management vary according to the needs of the organization, and many models are available for risk analysis (e.g., Failure Mode Effects Analysis (FMEA), Hazard and Operability Analysis (HAZOP), Hazard Analysis and Critical Control Poi

14、nts (HACCP), and fish-bone analysis). However, these models are not one size fits al, and may require modifications to suit their intended uses. The approach chosen for this technical report is a modified FMEA model, although the task force recognizes that other models may be used.质量风险管理具体方法因组织需要而异，

15、并且有多种风险分析模式(如：失效模式影响 分析法(FMEA),危害与可操作性分析法(HAZe)P),灾害分析与关键控制点(HAeCP),和 鱼骨分析法等)可以使用。但是，这些模式并非放诸四海而皆准的，可能需要根据其预 期的用途加以完善。虽然工作团组认同其他方法也可采用，但本技术报告所选的模式是 失效模式影响分析法。The ICH Q9 guideline, Quality Risk Management (QRM) and other literature provide ample guidance on the principles of quality risk management a

16、nd may be consulted for greater detail about alternative methods or approaches. This report docs nor attempt to redefine. or modify those principles; instead, the purpose of this report is to describe a methodology for implementing those principles, specifically for aseptic processing of sterile drug products.ICH-Q9指南，质量风险管理(QRM)以及其它文