Page 19 - 《中国药房》2021年20期

关于构建省级检验机构药品抽检标准/方法数据库的思考

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蔡丹宁 ，何开勇，程 樱，孙春艳 ，张 浩，陈莉萍，万 鑫，杨玉娇（湖北省药品监督检验研究院，武汉
＊
430075）

中图分类号 R927.11 文献标志码 A 文章编号 1001-0408（2021）20-2445-05
DOI 10.6039/j.issn.1001-0408.2021.20.03

摘 要 目的：为提高我国药品质量抽查检验工作运行效率提供参考。方法：从省级检验机构检验标准/方法应用管理实际出发，
分析目前省级检验机构检验标准/方法应用管理中存在的问题，并结合美国FDA的相关经验和做法，尝试构建省级检验机构检验
标准/方法数据库。结果与结论：抽查检验中涉及的检验标准/方法可分为法定标准和非标方法两类，法定标准是抽查检验中的标
准主体，主要用于常规检验，检验机构可按成册标准、单页标准和后期补充性方法分类，并建立电子目录对其进行统一管理。非标
方法仅用于样品初筛、法定检验结果验证、质量评价及应急检验中未知或可疑样品的检验。其跟踪收集和分类管理机制尚不健
全，建议借鉴美国药品抽查检验中的方法分层次建立方法库，对于药监系统建立的成熟方法，应建立电子目录及文件内容数据库，
使用前进行确认；对于其他行业中涉及药品的国家标准及权威机构公布的推荐性方法、科技文献中发表的成熟方法，应列出其检
索渠道，使用前须经过验证、审核、批准，使用后应建立电子目录并及时记录。非标方法电子目录格式一般应包括受控编号、适用
品种名称、方法名称、检验项目等。
关键词 药品质量抽查检验；法定标准；非标方法；数据库

Thoughts on the Construction of Standard and Method Database for Drug Quality Sampling and
Inspection in Provincial Inspection Institutions
CAI Danning，HE Kaiyong，CHENG Ying，SUN Chunyan，ZHANG Hao，CHEN Liping，WAN Xin，YANG Yujiao
（Hubei Institute for Drug Control，Wuhan 430075，China）

ABSTRACT OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection
in China. METHODS：Starting from the application and management situation of inspection standards/methods in provincial
inspection institutions，the problems existing in the application and management of inspection standards/methods in provincial
inspection institutions were analyzed；the inspection standards/methods database of provincial inspection institutions is attempted to
build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS：The inspection methods
involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were
the main standards for drug sampling and inspection，and were mainly used for routine inspection. Such kind of standards could be
classified according to the characteristics of compiled，single-page and later-issued supplementary；an electronic catalogue should
be established for unified management. Non-standard methods were only used for sample preliminary screening，verification of
official inspection results，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its
tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug
sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in
drug supervision system，an electronic catalog and document content database should be established and the method should be
confirmed before use；for national standards and the recommended methods published by authoritative institutions in other
industries，and mature methods published in scientific and technological literature，the retrieval channels should be listed，the
methods should be verified，reviewed and approved before use，and an electronic catalogue should be established and recorded in
time after use. The electronic catalogue format of non-standard methods generally include controlled number，applicable variety
name，method name，inspection items，etc.
KEYWORDS Drug quality sampling and inspection；Official standard；Non-standard method；Database

＊主管药师，硕士。研究方向：药品标准与药品质量控制。电话： 药品质量抽查检验（以下简称为“药品抽检”）是我
027-87705203。E-mail：461654469@qq.com
国实施药品上市后监管与再评价的重要技术手段之一，
# 通信作者：高级工程师，副主任药师。研究方向：化学药品分析
在查控假劣药品、震慑不法企业、消除安全隐患，以及评
与药品质量控制。电话：027-87705209。E-mail：suncy@126.com

中国药房 2021年第32卷第20期 China Pharmacy 2021 Vol. 32 No. 20 ·2445 ·