分析方法的验证、确认和转移 - US Pharmacopeial Convention.PDF

邀请函 Invitation 美国药典委员会中华区总部诚挚地邀请您参加将在广州举办的药典培训课程。 USP-China sincerely invites you to attend the following USP Pharmacopeial Education course. 分析方法的验证、确认和转移 Validation, Verification and Transfer of Analytical Procedures 时间/地点 Time/Location: 2013 年6 月13-14 日 Jun. 13-14, 2013 广州市 Guangzhou, China 课程简介 Course Description: 作为美国药典委员会推出的高级强化课程之一，“分析方法的验证、确认和转移”是根据美国药典最新要求，为 1224、1225 、1226一组通则开发的课程，旨在对制药及相关企业数据采集过程的质量控制提供专业指导。 根据美国药典通则1225要求和 ICH 指导原则，课程详细阐述小分子物质分析方法验证的性能参数（鉴别、杂质、 含量分析等）和通则1226法定方法确认的要求。同时，课程涉及在 USP35-NF30 中新增通则1224方法转移的内容， 向您介绍分析方法转移的流程构架、方法转移的类别 （包括转移免除的可能性和转移过程的要素）、影响分析方法转移 的重要因素、以及可采取的不同策略。此外，课程还将简单介绍分析小分子物质的色谱方法。课程以丰富详实的案例分 析、灵活热烈的小组讨论形式，对美国药典相关标准进行深入解析，使您对美国药典分析方法验证、确认和转移标准要 求的理解更加深入和可操作。 As a newly enhanced course, “Validation, Verification and Transfer of Analytical Procedures” covers a family of General Chapters devoted to providing guidance for the quality of data-acquisition process. It reviews parameters for validating analytical procedures for small molecules based on the USP General Chapter 1225 and ICH guideline. General Chapter 1226 Verification of Compendial Procedures and the new General Chapter 1224 Method Transfer will be discussed. It summarizes the types of transfers that may occur, including the possibility of waiver, and outline the components of a transfer process. In addition, it will cover the new General Chapter 1224 Method Transfer developed to provide a framework for analytical method transfer, examine different strategies, and discuss key factors that would influence the transfer of analytical methods from one site to another. Due to the time limitations, this course will also limit to chromatographic methods for analysis of small molecules. 参加对象 Who Should attend: 与分析方法验证、确认和转移工作相关的QA/QC部门、研发部门、项