原料药研发流程－中英文.doc

Active Pharmaceutical Ingredients (API) Development Stages 原料药研发步骤 步骤 Chemistry, Manufacturing Control (CMC) 化学，生产和控制工作描述 CGMP Perspective CGMP活动简述 1 a) Define the target API 确定目标原料药 b) Conduct patent and literature search to gain information on compound expiration date as well as synthetic chemistry regarding the preparation of the target API. 针对目标原料药进行专利和文献信息的研究，获取该化合物或混合物的专利到期信息和化学合成信息。 Form a project team, including the people from the following groups: 创建一个项目团队，包括下述团体成员： QA质量保证 QC质量控制 R D研发 Manufacturing生产 Engineering工程 Regulatory affair法规事务 The team’s responsibility should include (but not limit to): 团队的职责应当包括但不限于下列内容： Establish a time table for developing the API. 创建研发原料药的时间计划； Schedule regular meetings (such as once a month) to discuss any related issues and make any plans 定期（例如每月一次）讨论任何相关问题并制订实施计划； Monitor any progress of on-going project. 监管正在进行的项目的进展情况 System based CGMP auditing should be conducted to identify any deficiencies. 执行基于六大系统的CGMP审计以寻找任何GMP缺陷或不足。 Training should be scheduled to provide CGMP related subjects based on the deficiencies found. 根据发现的GMP缺陷进行相关的CGMP培训。 Note: 备注 ICH Q7A can be used as primary reference. ICHQ7A可以作为初步参考依据。ICHQ7A是原料药的GMP指南 2 a) Propose reasonable synthetic routes, and identify key starting materials (SM), their commercial availability (sources) and define the specifications. 计划可行的合成路径，确定关键的起始物料，这些物料的商业可用性（来源等），并确定其技术规格。 Define the interim quality standard or specifications (if possible) for the final API based on 依据下列信息确定最终原料药的中间体的质量标准或技术规格（如果可能） USP or EP monographs美国药典或欧盟药典的专论 Literature information文献信息 Other其它 Documentation相关文件  3 Develop a practical synthetic route (it is scalable and not infringe any patents) and obtain the API in reasonable quantity for analytical method development and other studies. 创建一个成熟的合成路径（是可放大的和没有侵犯任何专利的），获取一定数量的原料药用于分析方法的发展和其它研究 Testing key SM and other raw materials and establish their acceptance limits 测试关键起始物料和其它原材料并创建它们的接收标准 Develop analytical methods, especi