蔡丹寧 何開勇 程櫻 孫春艷 張浩 陳莉萍 萬鑫 楊玉嬌

中圖分類號 R927.11 文獻標志碼 A 文章編號 1001-0408（2021）20-2445-05

DOI 10.6039/j.issn.1001-0408.2021.20.03

摘 要 目的：為提高我國藥品質(zhì)量抽查檢驗工作運行效率提供參考。方法：從省級檢驗機構(gòu)檢驗標準/方法應(yīng)用管理實際出發(fā)，分析目前省級檢驗機構(gòu)檢驗標準/方法應(yīng)用管理中存在的問題，并結(jié)合美國FDA的相關(guān)經(jīng)驗和做法，嘗試構(gòu)建省級檢驗機構(gòu)檢驗標準/方法數(shù)據(jù)庫。結(jié)果與結(jié)論：抽查檢驗中涉及的檢驗標準/方法可分為法定標準和非標方法兩類，法定標準是抽查檢驗中的標準主體，主要用于常規(guī)檢驗，檢驗機構(gòu)可按成冊標準、單頁標準和后期補充性方法分類，并建立電子目錄對其進行統(tǒng)一管理。非標方法僅用于樣品初篩、法定檢驗結(jié)果驗證、質(zhì)量評價及應(yīng)急檢驗中未知或可疑樣品的檢驗。其跟蹤收集和分類管理機制尚不健全，建議借鑒美國藥品抽查檢驗中的方法分層次建立方法庫，對于藥監(jiān)系統(tǒng)建立的成熟方法，應(yīng)建立電子目錄及文件內(nèi)容數(shù)據(jù)庫，使用前進行確認;對于其他行業(yè)中涉及藥品的國家標準及權(quán)威機構(gòu)公布的推薦性方法、科技文獻中發(fā)表的成熟方法，應(yīng)列出其檢索渠道，使用前須經(jīng)過驗證、審核、批準，使用后應(yīng)建立電子目錄并及時記錄。非標方法電子目錄格式一般應(yīng)包括受控編號、適用品種名稱、方法名稱、檢驗項目等。

關(guān)鍵詞 藥品質(zhì)量抽查檢驗;法定標準;非標方法;數(shù)據(jù)庫

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.