Risk Control Study for Oral Solution Generic Drug Development Programs Based on ICH Q9Guidelines
庞海参PANG Hai-shen
(西安石油大学经济管理学院,西安710065 )
( School of Economics and Management,Xi an Shiyou University , Xi an 710065,China)
摘要;药品研发阶段高质量风险管理是确保药品安全、有效和质量可控的关键。本文基于ICH Q9质量风险管理指南,开展口服溶液仿制药研发项目风险控制研究,旨在实现该指南在特定项目研发阶段中的最佳实践.首先,通过流程图法和头脑风暴法识别药学研究不同阶段的各类风险;其次,采用危害分析及关键控制点法(HACCP)和专家评分法进行风险分析和评估;最后,根据风险级别制定科学的风险控制策略。研究结果表明,口服溶液仿制药研发项目应重点关注项目市场价值、专利可行性、技术开发与转移以及注册法规等高风险指标。提前制定科学有效的风险应对策略,并及时就风险事件进行监控、记录和处理。通过该研究,可有效识别、评估和控制口服溶液仿制药研发项目药学研究中的主要风险,实现项目进度、质量和成本的有效控制,最终实现项目高效率成功上市。
Abstract: High quality risk management in the drug research and development stage is the key to ensuring drug safety, effectivet ess,and controllabe quality. This article is based on the ICH 09 (Quality Risk Management Guidelines and conducts research on risk contro for oral solution generic drug development projecls, aiming to achieve the best practices of the guidelines during specific project developmentstages. Firstly, identify various risks at diffrent sltages of pharmaceutical research through flowchart and brainstorming methods;Secondly,haardl analysis and crtical control point method (HACCP and expert scoring method are used for risk analysis and assessment;Finally,develop a scientific risk control strategy based on the level of risk. Tlhe research resuls indicate that oral solution generic drng developmentpojects should focus on high-risk indicators such as project market value， patent feasibility，technology development and transfer, andregistation regulations. So it is necessary to develop scientific and effective risk response strategies in advance, and monitor, recordl, andhandle risk events in a timely manner. Through this stuly， the main risks in pharmaceutical research of oral solution generic drugdevelopment projects can be effectivel identified, evaluated, and controlled, achieving effective control of project progress, quality, and cost,and ultimately achieving efficient and successful project launch.
关键词:仿制药研发项目;风险控制; ICH Q9质量风险管理指南
Key words: generic drug development project; risk control; ICH Q9quality risk management guidelines
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