药品分析及微生物控制技术专题 研讨会顺利举办
国家对全面提高药品安全保障能力，降低药品安全风险提出了更高的要求，近年来，药品微生物的标准和监控要求不断提升。2022年8月份欧盟发布了新版GMP无菌药品附录，明确提出了污染控制策略CCS的概念；2023年 2月药品审评中心发布了《非无菌化学药品及原辅料微生物限度研究技术指导原则》。为促进中山市医药行业技术发展，提升微生物实验室GMP符合性，中山市药学会在11月17日顺利举办了“药品分析及微生物控制技术专题研讨会”，各企业代表50余人参加。
研讨会活动现场
研讨会邀请了靳贵英指导讲师和林铁豪授课老师出席参加，林博士分两个专题给大家讲授微生物检测技术合规性培训及微生物检测实验室质量管理要求，专题一 ：微生物检测技术合规性培训专题二：微生物检测实验室质量管理要求。
林铁豪博士授课
林博士在专题一中重点讲述了以下内容：中国药典2025版无菌检查法修订情况及实验要点分析、中国药典2025版微生物限度检查法修订情况及实验要点分析、非无菌药品生产中的微生物质量考量、《非无菌化学药品及原辅料微生物限度研究技术指导原则》介绍、方法适用性开发策略及案例分析。
林博士在专题二中重点讲述了基于中国药典9203的微生物实验室管理规范及核查介绍。
会上各企业代表认真学习做笔记，有的代表还积极向林博士提问，林博士耐心解答疑问，企业代表们都非常满意，夸赞林博士授课精彩绝伦，纷纷鼓掌表示感谢。
通过此次药品分析及微生物控制技术专题研讨会，给各企业代表带来了学习和交流的机会，更深入了解微生物检验技术的合规性操作和微生物检验实验室质量的管理要求。
中山市药学会
2023年11月25日
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