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·药事管理·

《药品质量抽查检验管理办法》与《药品质量抽查检验管理规定》

中检验和复验内容的对比分析 Δ

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刘 文 ，朱 炯 ，胡 骏 ，王 翀 ，胡增峣（1.中国食品药品检定研究院技术监督中心，北京 102629；2.上
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海市食品药品安全研究中心，上海 200233；3.国家药品监督管理局药品监督管理司，北京 100037）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）14-1665-06
DOI 10.6039/j.issn.1001-0408.2020.14.01

摘 要 目的：为药品抽检工作相关人员理解并执行《药品质量抽查检验管理办法》中的新要求提供参考。方法：对比《药品质量
抽查检验管理办法》和《药品质量抽查检验管理规定》中对检验和复验工作的要求，分析修订或新增内容并提出实施建议。结果与
结论：针对药品监管需要，在《药品质量抽查检验管理规定》的基础上，《药品质量抽查检验管理办法》对检验和复验工作的相关要
求进行了修订和补充。在对检验工作的要求中，该办法修订了检验项目要求，明确了检验时限要求，新增了检验报告、原始记录、
质量管理体系要求以及“严重风险”的定义及报告要求，对检验机构提出了开展探索性研究的要求，并新增了检验机构和检验人员
行为要求。在对复验工作的要求中，该办法修订了申请复验应提交的资料，增加了经办人身份证明、时限证明，修订了不得复验的
情况，增加了检出为明显可见异物时的处理方式，并新增了复验报告传递要求。建议药品检验工作的相关人员关注上述变更内
容，加强检验能力建设，加强检验时间和检验质量管理，重视严重质量风险，积极开展探索性研究，并加强对自身检验行为的规范；
严格审核复验资料，重视新修订的不得复验的情形，并应按要求和实际情况全面传递复验报告，积极执行并落实《药品质量抽验管
理办法》。
关键词 药品质量抽检管理；检验；复验；对比分析
Comparative Analysis of Test and Retest Contents between the Management of Drug Quality Sampling and
Testing and the Regulation of Drug Quality Sampling and Testing
LIU Wen ，ZHU Jiong ，HU Jun ，WANG Chong ，HU Zengyao（1. Center of Technical Supervision，National
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Institutes for Food and Drug Control，Beijing 102629，China；2. Shanghai Center for Food and Drug Safety
Research，Shanghai 200233，China；3. Dept. of Drug Regulation，National Medical Products Administration，
Beijing 100037，China）
ABSTRACT OBJECTIVE：To provide reference for the relevant personnel of drug quality sampling and testing to understand and
implement the new requirements in the Management of Drug Quality Sampling and Testing. METHODS：The test and retest
requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality
Sampling and Testing. The revised and newly added contents were analyzed，and the recommendations for implementation were put
forward. RESULTS & CONCLUSIONS： Referring to drug regulation need， related requirements of test and retest in the
Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality
Sampling and Testing. In the requirements for test，the requirements for test items were revised，the requirements for test time limit
were confirmed，the requirements for test report，original record and quality management system，the definition of“serious risk”
and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions，
as well as new requirements for test institutions and inspectors’behaviors. In the requirements for retest，the materials to be
submitted for retest were revised，and the identity certificate of the manager and time limit certificate were added；the situation of
no-retest were revised，and the treatment method were added when obviously visible foreign matters were detected；transfer
requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above
changes，strengthen the construction of test capacity and the management of test time and quality，attach importance to serious
quality risks， actively carry out exploratory research， and
Δ 基金项目：国家重点研发计划项目（No.2016YFE0205400）
mind their own test behaviors；strictly review retest materials，
＊主管药师。研究方向：药品抽检与法规。电话：010-53851420。
E-mail：liuwen@nifdc.org.cn pay attention to the newly revised no-test and comprehensively
#通信作者：副主任药师。研究方向：药品抽检与法规。电话： transfer the retest report according to the requirements and
010-53851418。E-mail：wangchong@nifdc.org.cn actual situation，conduct and implement the Management of

中国药房 2020年第31卷第14期 China Pharmacy 2020 Vol. 31 No. 14 ·1665 ·