Article(id=1322626720709067765, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1585670400000, acceptedDateStr=2020-04-01, onlineDate=1793268383433, onlineDateStr=2026-10-29, pubDate=1610640000000, pubDateStr=2021-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268383433, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268383433, creator=13701087609, updateTime=1793268383433, updator=13701087609, issue=Issue{id=1322626690153562922, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='1', pageStart='1', pageEnd='93', issueExtLink='null', onlineDate='null', pubDate='1610640000000', pubDateStr='2021-01-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268376148, creator='13701087609', updateTime=1793269030229, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629433626837820, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629433626837821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=13, endPage=16, ext={EN=ArticleExt(id=1322626720902005750, articleId=1322626720709067765, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Key points on direct distribution for national drug reference standards, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Reference standards are important material basis for drug control, meanwhile legal distribution of the national drug reference standards is one of the basic functions of NIFDC. A reform of distribution model for reference standard has been carried out by NIFDC in 2019, which changed the past two-level distribution and fully implemented direct distribution to users. Some key points are applied by NIFDC who faces the increasing workload and strict quality control requirements, including adjusting process links, establishing distribution traceability system, founding 9 steps of packaging procedure, building limitation of transportation and so on. As a result, smooth transition to direct distribution was realized. In order to provide guidance to improve the efficiency of reference standard management, this article summarizes the methods of efficiency improvement, analyzes the strategies of quality control, and combs the process nodes. In addition to the above points, some conclusions are made, such as the foundation to direct distribution was providing resources effectively, the powerful tool was intelligent external distribution platform, the significant guarantee was training and guiding users to order correctly.

, authors=Zhi-feng GAO, Xin-yue XIAO, Li-mei CAO, Li-hua XIE, Jing-yu JIANG, Jun-juan SHAO, authorsList=Zhi-feng GAO, Xin-yue XIAO, Li-mei CAO, Li-hua XIE, Jing-yu JIANG, Jun-juan SHAO, authorCompany=null, correspAuthors=Xin-yue XIAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322626721183024119, articleId=1322626720709067765, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=国家药品标准物质一级直供的实施要点研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

标准物质是药品检定的重要物质基础，法定供应国家药品标准物质是中国食品药品检定研究院（简称中检院）的主要职能之一。2019年，中检院对标准物质的供应模式实施了改革，改变两级供应而全面实施一级直供，面对激增的工作量与严格的质量控制要求，中检院通过调整部分工序环节、建成分发可追溯制度、建立9步包装工序、约束运输时效等措施，基本实现了平稳过渡。本文通过对效率改进的方法进行归纳，对质量控制的策略进行分析，对工作环节进行梳理，提炼形成上述实施要点，并汇总得出有效调配资源是基础、智能的对外供应平台是抓手、培训和指导用户正确订购是保障的综合结论，为进一步提高标准物质管理的工作效率提供参考。

, authors=高志峰, 肖新月, 曹丽梅, 谢丽华, 姜晶钰, 邵俊娟, authorsList=高志峰, 肖新月, 曹丽梅, 谢丽华, 姜晶钰, 邵俊娟, authorCompany=null, correspAuthors=肖新月, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=BWtCqJFu6aAcI+gJPlSknA==, magXml=W9XaUCmvyZPp2PG0s8SBPQ==, pdfUrl=null, pdf=z5pPFqMWpH8ZQSEBWq1W7Q==, pdfFileSize=848487, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=DIBVBLszFC/ZC/Ro33ZbjQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322626721610843132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626720709067765, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=gaozhifeng@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322626723343090686, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626720709067765, authorId=1322626721610843132, language=EN, stringName=Zhi-feng GAO, firstName=Zhi-feng, middleName=null, lastName=GAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=National Institute for Food and Drug Control, Beijing 102629, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322626723552805887, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626720709067765, authorId=1322626721610843132, language=CN, stringName=高志峰, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=中国食品药品检定研究院，北京　102629, bio={"content":"

高志峰，男，主任技师，主要从事药品检验技术审核与标准物质管理工作。联系电话：（010）53852496，E-mail：gaozhifeng@nifdc.org.cn。

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高志峰，男，主任技师，主要从事药品检验技术审核与标准物质管理工作。联系电话：（010）53852496，E-mail：gaozhifeng@nifdc.org.cn。

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