Article(id=1236334169970758113, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, 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=1678809600000, acceptedDateStr=2023-03-15, onlineDate=1772694636098, onlineDateStr=2026-03-05, pubDate=1689350400000, pubDateStr=2023-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694636098, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694636098, creator=13701087609, updateTime=1772694636098, updator=13701087609, issue=Issue{id=1236334167978472434, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='13', pageStart='1281', pageEnd='1384', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694635624, creator=13701087609, updateTime=1772696111905, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236340360004292707, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236340360004292708, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334167978472434, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1309, endPage=1314, ext={EN=ArticleExt(id=1236334170302108136, articleId=1236334169970758113, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Introduction and interpretation of U.S. FDA Inspection of Injectable Products for Visible Particulates Guidance for Industry (draft guidance), columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Visible particulates in injectable products directly jeopardize patient safety, and it is a critical quality attributes of injectable products. In recent years, unqualified products and recall events related to injectable products caused by visible particulates occurred frequently. Therefore, it is necessary to conduct the risk assessment, production process control and product detection of visible particulates in injectable products. Referring to the U.S. FDA Inspection of Injectable Products for Visible Particulates Guidance for Industry (draft guidance) and relevant guidelines and manufacturing and controls (CMC) review experience, this article mainly introduces and discusses the ideas of visible particulate control in chemical injections from the aspects like concept of visible particulates, quality risk assessment, production process and sample inspection control, life cycle management, etc., hoping to provide reference for the control and evaluation of visible particulates in injections.

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注射剂中的可见异物直接关系到患者用药安全，是注射剂一项重要的质量指标，近年来可见异物检查不合格以及由此引起的注射剂召回事件频发。因此，注射剂中可见异物的风险评估、生产过程控制和产品检验应引起高度重视。本文参考美国FDA发布的《注射剂可见异物检查行业指南（草案）》，同时结合国内外相关指南和审评工作，从可见异物概念、风险评估、生产过程控制和样品检查、生命周期管理等方面对注射剂可见异物的控制策略进行介绍，以期为我国注射剂可见异物的控制和评价提供参考。

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李越，女，工程师，主要从事化学药品技术审评工作。E-mail: liy@cde.org.cn。

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李越，女，工程师，主要从事化学药品技术审评工作。E-mail: liy@cde.org.cn。

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