化学药品药学研究风险管理过程探究  

Risk Management Process of Pharmaceutical Research in Chemicals

作　　者：黄滔 金鑫 李光州 HUANG Tao;JIN Xin;LI Guangzhou(Livzon Pharmaceutical Group Co.,Ltd.,Zhuhai,Guangdong,China 519090)

机构地区：[1]丽珠医药集团股份有限公司,广东珠海519090

出　　处：《中国药业》2021年第23期8-10,共3页China Pharmaceuticals

基　　金：广东省珠海市产业核心和关键技术攻关方向项目[ZH01084702180030HJL]。

摘　　要：目的提高化学药品的研发成功率。方法采用文献研究法和调查研究法,借鉴风险管理理论,总结化学药品药学研究过程中存在的风险因素,并提出针对性的应对策略。结果导致化学药品药学研究失败的风险因素包括技术、生产、管理风险,针对上述风险分别提出应对策略。针对技术风险,从团队组建、引进行业顶尖专家、加强技术培训、发挥外包的第三方优势进行控制;针对生产风险,从生产设备信息调研及项目预算、保证生产车间设计符合《药品生产质量管理规范》要求、委托有生产资质的第三方生产、选择A级原辅料等方面进行控制;针对管理风险,从制订提高药学研究质量的培训计划及管理制度、加强研发与生产人员的沟通协调、提前预判实验室研究与生产放大研究的进度进行控制。结论化学药品药学研究团队需重视研究过程中的风险因素,并采取必要风险管理措施,以规避化学药品药学研究过程中的风险。Objective To improve the success rate of research and development(R&D)of chemicals.Methods The risk factors in the pharmaceutical research in chemicals were summarized through literature research method,survey research,and the risk management theory,and the countermeasures were put forward.Results The risk factors leading to the failure of pharmaceutical research in chemicals in-cluded technology,production and management risks,and corresponding countermeasures were put forward for the above risks.In view of the technology risks,control was carried out from team building,introducing top experts in this industry,strengthening technical training and giving full play to the third-party advantage of outsourcing.In view of production risks,control was carried out from the informal survey of production equipment and project budget,ensuring that the design of the production workshop could meet the requirements of the Good Manufacturing Practice(GMP)for drugs,entrusting a third-party production company with production qualification to produce,selecting class-A active pharmaceutical ingredients and excipients,etc.In view of management risks,control was carried out from formu-lating the training plan and management system to improve the quality of pharmaceutical research,strengthening the communication and coordination between R&D and production personnel,and predicting the progress of laboratory research and production scale-up re-search.Conclusion The pharmaceutical research team of chemicals should pay attention to the risk factors in the research process and take necessary risk management measures to avoid the risks in the process of pharmaceutical research in chemicals.

关 键 词：化学药品 药学研究 风险因素 药品管理 

分 类 号：R954[医药卫生—药学]