严守药典规范，践行行业自律 2025年版《中国药典》微生物增修订内容和 技术要点专题培训圆满结束
2025年9月10日下午，由中山市药学会主办、中山市医药行业协会协办的“2025年版《中国药典》微生物增修订内容和技术要点专题培训班”顺利举行。本次培训旨在帮助制药企业、医疗机构及相关单位深入理解新版药典微生物检验与控制要求，提升行业质量控制水平，吸引了近百名药品研发、生产、经营及医疗机构的质量管理骨干到场参与。
培训伊始，中山市药学会副秘书长朱银春发表开场致辞。她首先对参会人员的学习热情表示高度肯定，充分体现了业界对新版药典的重视。希望通过此次培训，帮助企业精准把握微生物检验领域的技术变革，为药品质量安全保驾护航。随后，她隆重介绍了本次培训的主讲专家——林丽英主任药师，林主任是国家药典委员会微生物专业委员会委员、广东省药品检验所原微生物室主任，深耕药品微生物检验领域数年，参与《中国药典》2000年版至2025年版各版本微生物相关内容的增修订工作，其丰富的实践经验与权威解读备受期待。
系统梳理标准体系，深入剖析增修订内容。培训中，林丽英主任围绕“微生物标准控制体系的发展与革新”展开讲解，系统回顾了药典微生物检验标准的沿革历程，并重点解读了2025年版药典的编制大纲及核心构成。她指出，新版药典在微生物检查法、标准与指导原则方面进行了多项优化调整，尤其强化了药品全生命周期的微生物风险管控。结合具体案例，她详细分析了微生物实验室常见问题，涵盖培养基质控、菌种管理、限度检查、无菌检查、抑菌效力检测及药包材微生物检验等关键环节，为企业应对技术挑战提供了清晰的解决方案。
互动答疑解惑，实践指导性强。在互动环节，现场企业代表纷纷结合实际工作中遇到的微生物检验难题积极提问，林丽英主任逐一解答，现场气氛热烈。参训人员纷纷表示，此次培训内容贴合实际需求，既有理论深度又有实操指导，对即将实施的新版药典执行工作具有重要指导意义。
强化行业规范，助力高质量发展。本次培训是落实国家药品监管要求、推动行业技术升级的重要举措。通过专家解读与经验分享，进一步提升了企业对新版药典微生物检验要求的理解与执行力，为保障药品质量安全、促进行业规范化发展奠定了坚实基础。未来，协会将持续关注政策动态，搭建更多交流平台，助力大湾区生物医药产业高质量发展。
中山市药学会
2025年9月11日
{"weixin":{"label":"微信","name":"weixin","selected":true,"value":true,"sortid":"1","shareid":"weixin","sharetitle":"分享到微信","event":"shareToWeiXin","lang":"shareWeb_WeiXin"},"copy":{"label":"复制网址","name":"copy","selected":true,"value":true,"sortid":"2","shareid":"copy","sharetitle":"复制网址","event":"copy_url","lang":"shareWeb_Copy"},"qq":{"label":"QQ好友","name":"qq","selected":true,"value":false,"sortid":"1","shareid":"qq","sharetitle":"分享到QQ","event":"shareToQQ","lang":"shareWeb_QQ"},"sina_weibo":{"label":"新浪微博","name":"sina_weibo","selected":true,"value":true,"sortid":"4","shareid":"sina_weibo","sharetitle":"分享到新浪微博","event":"shareToSinaWB","lang":"shareWeb_SinaWeiBo"},"qq_zone":{"label":"QQ空间","name":"qq_zone","selected":true,"value":true,"sortid":"5","shareid":"qq_zone","sharetitle":"分享到QQ空间","event":"shareToQzone","lang":"shareWeb_QQZone"},"renren":{"label":"人人网","name":"renren","selected":true,"value":false,"sortid":"7","shareid":"renren","sharetitle":"分享到人人网","event":"shareToRenren","lang":"shareWeb_RenRen"},"douban":{"label":"豆瓣网","name":"douban","selected":true,"value":true,"sortid":"8","shareid":"douban","sharetitle":"分享到豆瓣网","event":"shareToDouban","lang":"shareWeb_DouBan"},"baidu_tieba":{"label":"百度贴吧","name":"baidu_tieba","selected":true,"value":true,"sortid":"10","shareid":"baidu_tieba","sharetitle":"分享到百度贴吧","event":"shareToTieba","lang":"shareWeb_TieBa"},"Facebook":{"label":"Facebook","name":"Facebook","selected":true,"value":false,"sortid":"11","shareid":"Facebook","sharetitle":"分享到FaceBook","event":"shareToFacebook","lang":"shareWeb_Facebook"},"Twitter":{"label":"Twitter","name":"Twitter","selected":true,"value":false,"sortid":"12","shareid":"Twitter","sharetitle":"分享到Twitter","event":"shareToTwitter","lang":"shareWeb_Twitter"},"LinkedIn":{"label":"LinkedIn","name":"LinkedIn","selected":true,"value":false,"sortid":"13","shareid":"LinkedIn","sharetitle":"分享到linkedIn","event":"shareToLinkedin","lang":"shareWeb_Linkedin"},"whatsapp":{"label":"whatsapp","name":"whatsapp","selected":true,"value":false,"sortid":"15","shareid":"whatsapp","sharetitle":"分享到whatsapp","event":"shareToWhatsapp","lang":"shareWeb_whatsapp"},"line":{"label":"line","name":"line","selected":true,"value":false,"sortid":"15","shareid":"line","sharetitle":"分享到line","event":"shareToLine","lang":"shareWeb_line"},"qq_weibo":{"label":"腾讯微博","name":"qq_weibo","selected":true,"value":true,"sortid":"3","shareid":"qq_weibo","sharetitle":"分享到腾讯微博","event":"shareToQQwb","lang":"shareWeb_QQWeiBo"}}