PIC_S_GMP先进治疗...生产质量管理指南的对比分析_孙程洁.pdf

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品生产质量管理指南的对比分析

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孙程洁，成殷，俞佳宁（上海药品审评核查中心，上海201203）

摘要目的：为我国申请加入药品检查合作计划（PIC/S），建立与国际统一的检查标准，提出细胞治

疗产品GMP检查亟需关注的差异点。方法：对我国细胞治疗产品指南与PIC/S先进治疗产品GMP附录进

行整体梳理和对比分析，并就一些关键问题进行了讨论。结果：我国与PIC/SGMP附录原则及考虑要素

基本是一致的，但从法规体系、框架结构、适用范围、具体要求均有所区别。结论：分别从质量风险管

理、起始生物材料的检查、与国际检查标准的统一三个方面提出了对此类产品GMP检查的启示。

关键词：药品检查合作计划；先进治疗产品；药品生产质量管理规范；细胞治疗；药品检查

R95A1002-7777(2023)05-0504-09

中图分类号：文献标识码：文章编号：

doi:10.16153/j.1002-7777.2023.05.003

ComparativeAnalysisoftheGMPAppendixofPIC/SAdvancedTherapeutic

MedicinalProductsandManufactureQualityManagementGuidelinesof

ChinasCellTherapyProducts

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SunChengjie,ChengYin,YuJianing(ShanghaiCenterforDrugEvaluationandInspection,Shanghai201203,

China)

AbstractObjective:ForChinatoapplyforjoiningthePharmaceuticalInspectionCo-operationScheme(PIC/S),

establishinternationallyunifiedinspectionstandards,andputforwardthedifferencesthatneedurgentattentionin

GMPinspectionofcelltherapyproducts.Methods:TheoverallcombingandcomparativeanalysisofChinascell

therapyproductguidelinesandtheGMPappendixofPIC/Sadvancedtherapeuticmedicinalproductswerecarried

out,andsomekeyissueswerediscussed.Results:TheprinciplesandconsiderationsofChinaandPIC/SGMP

appendixarebasicallythesame,buttheyaredifferentfromtheregulatorysystem,frameworkstructure,scopeof

application,andspecificrequirements.Conclusion:TheenlightenmentforGMPinspectionofsuchproductsis

proposedfromthreeaspects:qualityriskmanagement,inspectionofstartingbiologicalmaterials,andunification

withinternationalinspectionstandards.

Keywords:PharmaceuticalInspectionCo-operationScheme(PIC/S);AdvancedTherapyMedicinalProducts

(ATMP);GoodManufacturePractice(GMP);celltherapy;druginspection

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