基于风险确定验证范围和验证程度的必要性—以粉针生产线为例教程分析.docx

PAGE \* MERGEFORMAT51 PAGE \* MERGEFORMATI 摘 要 自2002年美国FDA提出的21世纪以风险为基础的CGMP以来，以风险为基础的法规体系和质量管理体系已逐渐广泛应用于欧洲、美国、日本等全球各医药卫生领域。中国SFDA2011年发布的《药品生产质量管理规范（2010年）》中也引进了风险管理程序，要求建立以风险为基础的质量管理体系。并明确提出应基于风险确定验证范围和验证程度。 本文以一条粉针注射剂生产线为例，通过分析粉针剂生产线的组成和影响因素和对验证的需求，讲述通过风险管理程序如何确定出该生产线的验证范围和程度，确证基于风险确定验证范围和验证程度是有效和必要的。基于风险确定验证范围和验证程度，能够将有限的资源着重于确认该生产线重要的或关键的组成及影响因素，从而确保产品质量，实现验证应有的目的和价值。 关键词：风险；验证范围；验证程度；粉针剂 The necessity To Define the Validation Scope and Degree Based on Risk -Take the Powder Injection Production Line For Example Since “Pharmaceutical CGMP for 21st Century Based On the Risk” was proposed by US FDA in 2002, Regulation and Quality system based on risk is increasingly wide utilized in Europe, USA, Japan and almost globally healthcare industry. Recently issued Chinese SFDA GMP 2010 also introduced the risk management program. The Quality System Based On Risk is required, and also make it clear that should define the validation scope and degree based on risk. The thesis takes a powder injection production line for example, describe how to define the scope and degree of the validation work by analysis the powder injection production line component s, quality impact elements, and the validation requirements, then to prove that it is effective and necessary to define the validation scope and degree based on the risk. Define the validation scope and degree based on the risk can focus the limited resources to qualify or validate the important or critical components or quality impact elements, to ensure the products quality and realize the goal and value of validation finally. Key Words: Risk, Validation scope, Validation Degree, Powder Injection  目　录  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc352627804 第一章 前言  PAGEREF _Toc352627804 \h 1  HYPERLINK \l _Toc352627805 第二章 粉针剂产品质量属性和生产工艺分析  PAGEREF _Toc352627805 \h 2  HYPERLINK \l _Toc352627806 2.1 粉针剂产品质量属性  PAGEREF _Toc352627806 \h 2  HYPERLINK \l _Toc352627807 2.2 粉针剂产品生产工艺  PAGEREF _Toc3