Article(id=1322245757642592360, 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=1608393600000, acceptedDateStr=2020-12-20, onlineDate=1793177554759, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177554759, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177554759, creator=13701087609, updateTime=1793177554759, 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=937, endPage=946, ext={EN=ArticleExt(id=1322245757814558825, articleId=1322245757642592360, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The quality control strategy based on process analytical technology in continuous manufacturing of solid dosage forms, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Continuous manufacturing (CM) of solid dosage forms enables materials passing through integrated dispensing system, saving operation time and reducing human errors, thus is developing into a preferred platform for pharmaceutical products. European and American drug regulatory agencies have approved several commercial CM solid dosage form drugs. The role of control strategy for CM is based on scientific framework to identify and to reduce the risk of manufacturing variation. Process analysis technology (PAT) monitoring methods can improve product quality in real time, promote continuous improvement and innovation in manufacturing, and thus achieve advanced process control and real-time release of products. The ultimate goal is to bring safer medicines to the market more quickly and cost-effectively, as well as to achieve the digitalization and process analytics of pharmaceutical 4.0. This review article discussed the modeling and associated risk mitigation, advanced control strategies of PAT in the implementation of CM processes for solid dosage form products, and the potential challenges of regulator's expectations from industrial perspective. The current situation of new drug approvals and related PAT implementations from international pharmaceutical companies were also illustrated and discussed.

, authors=Wen-bo ZOU¹, Gui-qin ZHOU², Su-qin LUO², Li-hui YIN¹, authorsList=Wen-bo ZOU, Gui-qin ZHOU, Su-qin LUO, Li-hui YIN, authorCompany=null, correspAuthors=Su-qin LUO, Li-hui YIN, 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=1322245758112354410, articleId=1322245757642592360, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=过程分析技术在制药连续制造的质量控制策略, columnId=1236330553964810454, journalTitle=中国新药杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

固体剂型连续制造（CM）中，物料通过完全集成设备的装配线，节省操作时间并降低人为错误发生的可能性，已逐渐发展成为药物产品的优选平台。欧美药品监督管理机构已批准了数个商业化连续生产的药品，其生产工艺控制策略的要素是采用科学框架来寻找降低制造过程发生变异的风险。过程分析技术（PAT）监控方法可实时控制产品质量，促进制造的持续改进和创新，从而实现先进过程控制和产品的实时放行。其最终目标是以更高效和更低的成本将更安全的药品迅速推向市场，实现制药工业4.0数据化及过程控制系统集成的目标。本文探讨了过程分析技术在实施连续制造工艺中的模型分类与风险考虑，先进控制策略、当今监管法规关注重点和可能面临的施行挑战，并介绍欧美制药企业基于连续制造的上市新药审批结果与PAT应用项目。

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邹文博，男，主任药师，研究方向：化学药品质量控制。E-mail：zwb@nifdc.org.cn。

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邹文博，男，主任药师，研究方向：化学药品质量控制。E-mail：zwb@nifdc.org.cn。

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