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目的探讨溶出度测定能力验证活动在相关实验室能力建设方面的作用。方法结合近年国内已开展的两次溶出度测定能力验证活动的结果,分析参与实验室在质量管理方面和溶出度测定技术上的能力水平,探讨未来的溶出度测定能力验证项目的策划和实施。结果各级实验室的能力水平存在差异,获得“不满意”结果的实验室主要集中在地市、区县级药检所和药品生产企业。首次溶出度测定能力验证活动中获“不满意”结果的3家实验室,采取了纠正预防措施,参与了第二次溶出度测定能力验证活动并取得了“满意”结果。结论借助能力验证的模式组织实验室比对是一种提高实验室溶出度测定能力的有效方法,建议在制药行业内持续开展溶出度测定能力验证活动。
Objective To explore the role of dissolution testing capability verification in capacity building of related laboratories. Methods Based on the results of two proficiency testing activities carried out in China in recent years, the capacity of participating laboratories in quality management and dissolution testing was analyzed, and the planning and implementation of future capacity testing programs for dissolution testing were discussed. As a result, laboratories at different levels have different levels of competence, and laboratories with “unsatisfied” results are mainly located in prefectural, district and county level drug testing institutes and drug manufacturers. Three laboratories that were “unsatisfied” in the first activity of dissolution proficiency testing were taken corrective and preventive measures, participated in the second dissolution activity proficiency verification activity and achieved “Satisfaction” results. Conclusion Comparing laboratory profiling with proficiency testing is an effective way to improve laboratory dissolution testing and recommends ongoing capacity testing of dissolution testing in the pharmaceutical industry.