Article(id=1322245734850736864, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, 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=1609171200000, acceptedDateStr=2020-12-29, onlineDate=1793177549326, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177549326, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177549326, creator=13701087609, updateTime=1793177549326, updator=13701087609, issue=Issue{id=1322245734427112160, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='10', pageStart='865', pageEnd='960', issueExtLink='null', onlineDate='null', pubDate='1622304000000', pubDateStr='2021-05-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177549225, creator='13701087609', updateTime=1793177686658, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246311269740715, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246311269740716, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=880, endPage=885, ext={EN=ArticleExt(id=1322245735014314721, articleId=1322245734850736864, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Introduction and interpretation of USP 〈1207〉 package integrity evaluation for sterile products, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Package integrity, which is synonymous with container-closure integrity, is the ability of a package to maintain product quality, including preventing microorganism ingress and ensuring that the product meets all necessary safety and quality requirement. Package integrity assessment begins at the product development phase and continues throughout the product life cycle, which is a key consideration in the manufacturing, quality research and evaluation of sterile products. This article mainly refers to the US Pharmacopeia (USP) 〈1207〉 guidelines, based on the understanding of CMC review experience, introduces and discusses the content of container-closure integrity, including concepts and scope, the requirements of different product life cycles, testing methods and validation, etc. It is hoped that the content of this article will provide some references for the quality study and evaluation of sterile pharmaceutical products.

, authors=Di-liang GUO, Wu-jun DONG, Jun-wei MA, Lu WANG, Zhong-jie LI, authorsList=Di-liang GUO, Wu-jun DONG, Jun-wei MA, Lu WANG, Zhong-jie LI, authorCompany=null, correspAuthors=null, 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=1322245735232418530, articleId=1322245734850736864, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《美国药典》〈1207〉无菌药品包装系统密封性评估的介绍与解读, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

包装系统密封性，又称容器密封完整性，是指药品的包装系统防止微生物侵入以及维持药品各项质量指标持续符合安全和质量要求的能力。包装系统密封性的研究始于产品的开发阶段，并持续贯穿产品生命周期，是无菌药品生产、质量研究和评价的一项重点关注内容。本文参考《美国药典》〈1207〉系列指导原则，从审评角度对无菌药品包装系统密封性的概念和范围、不同产品生命周期阶段的密封性要求、检测方法和验证等相关内容进行介绍和探讨，以期为国内无菌药品的质量研究和评价工作提供有益参考。

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郭涤亮，男，药学审评员，主要从事药品审评工作。E-mail：gdlzluck@163.com。

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郭涤亮，男，药学审评员，主要从事药品审评工作。E-mail：gdlzluck@163.com。

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unstructuredReference=CARROLL CM, DENNY VF, GUAZZO DM, et al. Technical report No.27-Pharmaceutical package integrity[J]. PDA J Pharm Sci Technol, 1998, 52(4): 1-48., articleTitle=null, refAbstract=null), Reference(id=1322245742899606285, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics (Chemistry, Manufacturing, and Controls Documentation)[S]. 1999., articleTitle=null, refAbstract=null), Reference(id=1322245742970909454, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Guidance for Industry: Q8 (R2) Pharmaceutical Development[S]. 2009., articleTitle=null, refAbstract=null), Reference(id=1322245743046406927, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国国家卫生健康委员会. 药品生产质量管理规范(2010年修订)(卫生部令第79号)[EB/OL]. [2011-02-12]. http://www.nhc.gov.cn/wjw/bmgz/201102/e1783dd3c9684f0cb875d71170a96d17.shtml., articleTitle=null, refAbstract=null), Reference(id=1322245743126098704, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=CDE. 化学药品注射剂仿制药质量和疗效一致性评价技术要求[EB/OL]. [2020-05-14]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=315069., articleTitle=null, refAbstract=null), Reference(id=1322245743235150609, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=USP. Package integrity evaluation-sterile products 〈1207〉[S]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743402922770, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=USP. Package Integrity Testing in the Product Life Cycle-Test Method Selection and Validation 〈1207.1〉[S]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743486808851, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=USP. Package Integrity Leak Test Technologies 〈1207.2〉[S]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743633609492, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=USP. Package Seal Quality Test Technologies 〈1207.3〉[S]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743721689877, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=GUAZZO DM, SINGER DC, STEVENS-RILEY M, et al. Proposed revisions to general chapter sterile product packaging-integrity evaluation 〈1207〉. Stimuli to the revision process[J]. Pharmacopeial Forum, 2014, 40(5): 47-61., articleTitle=null, refAbstract=null), Reference(id=1322245743801381654, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=USP. Validation of Compendial Procedures. 〈1225〉[S]. 2017., articleTitle=null, refAbstract=null), Reference(id=1322245743868490519, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=封二飞. 无菌药品包装完整性研究[J]. 中国医药工业杂志, 2019, 50(11): 126-131., articleTitle=null, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1322245735446328035, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, xref=null, ext=[AuthorCompanyExt(id=1322245735454716644, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245734850736864, companyId=1322245735446328035, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug 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