国家药品抽检检验机构调研现状及对策

Investigation and Analysis on National Drug Sampling and Testing

目的:通过梳理近年来国家药品抽检工作调研中发现的问题,聚焦质量管理体系运行情况,重点围绕抽检组织、样品管理、原始记录及报告书等问题进行分析,就如何在新的药品监管模式下做好抽检工作并提出建议,推动药品抽检管理模式的创新。方法:以数据完整性、真实性为重点,以检验报告为主线,通过审核程序文件、抽查检验报告、实地考察实验室并查看记录文件以及访谈工作人员等多种形式,调研2020年与2021年国家药品抽检完成情况,重点对抽检组织、样品管理、检验报告及记录、质量管理体系运行的有效性等进行全面核查。结果与结论:检验机构应确保各项数据与行为的合规性与可追溯性,促进药品抽样工作的科学性、合法性、代表性。

Objective: By sorting out the problems found in the investigation of the national drug sampling and testing in recent years, focusing on the operation of the quality management system, focusing on the sampling organization, sample management, original records and reports, etc., to put forward suggestions on how to do a good job in the sampling inspection under the new drug supervision mode, and promote the innovation of the drug sampling management mode. Methods: Focusing on the integrity and authenticity of the data and taking the test report as the main line, we reviewed the procedure documents,spot checked the test reports, inspected the laboratory on the spot and checked the record documents, and interviewed the staff. Through the completion of the national drug sampling inspection in 2020 and 2021,we focused on the overall inspection of the sampling organization, sample management, inspection reports and records, and the effectiveness of the operation of the quality management system. Results &Conclusion: The inspection institutions shall ensure the compliance and traceability of all data and behavior, and promote the scientific, legal and representative work of drug sampling.