美国药典制药用水要求汇编.pdfVIP

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北京举办的药典培训课程。 USP-China sincerely invites you to attend the following USP Pharmacopeial Education course. 美国药典制药用水要求 USP Perspectives on Pharmaceutical Waters 时间/地点 Time/Location: 2014 年11 月20-21 日 Nov. 20-21, 2014 北京 Beijing, China 课程简介 Course Description: 本课程由美国药典委员会总部制药用水通则专家亲临授课。课程将全面、详尽地阐述现行版美国药典对纯化 水、注射用水、纯蒸汽、血液透析用水、无菌注射水和其他无菌用水的标准要求。内容涵盖制药用水用途、化学 与微生物检测要求、检测方案、水纯化单元运作、电导率测量、总有机碳测量、生物膜、内毒素等。同时，还将 介绍现行欧洲药典和日本药典的相关制药用水要求，以及美国药典正在开展的制药用水标准修订等内容。 本课程旨在为专业负责监管审核、药典事务、质量、水处理、水系统设计和维护的人士提供专业指导和帮 助。通过学习，您将理解美国药典与制药用水相关的各论和通则要求，了解水质量和水化学单元运作的影响，学 会识别潜在污染的指征和现象，探讨多种潜在解决方案并评价其优劣，洞悉美、欧、日药典制药用水的最新要求 及其发展趋势。 This course provides comprehensive and specific compendial requirements for USP Purified Water, Water for Injection, Pure Steam, Water for Hemodialysis, Sterile Water for Injection, and several other Sterile waters. Course includes pharmaceutical waters usage, chemical and microbial testing requirements, testing strategies, water purification unit operations, conductivity measurement, total organic carbon measurement, biofilm, endotoxin, current EP and JP requirements, and pending USP initiatives. It is intended for the professional responsible for regulatory review, compendial affairs, water treatment/operations, maintenance, water system design, and quality. This coursw will help you understand the official requirements in water monographs and rela ted general chapters, Understand the impact of unit operations on water quality and chemistry, Identify signs and symptoms indicating potential contamination, Discuss potential solutions, evaluating the pros and cons of each solution, Know the current and future water initiatives. 参加对象Who Should a