欧盟原料药gmp认证检查项目

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1、欧盟原料药GMP认证检查项目GMPChecklistforActivePharmaceuticalIngredients(APIs)本GMP认证检查项目基于法规要求和个人经验。ThisGMPchecklistisbasedonregulatoryrequirementsandpersonalexperiences.I.组织和人员OrganizationandPersonnelA．质量部门责任ResponsibilitiesoftheQualityUnit(QU)企业应当建立独立的质量部门，质量部门应当参与所有与质量有关的活动Thereshould

2、beaQUthatisindependentofproduction.QUshouldbeinvolvedinallqualityrelatedmatters.质量部门负责所有物料、中间体和原料药的放行和拒收，以及所有与质量相关文件的审核和批准。QUhastheresponsibilitytorelease/rejectallmaterials,intermediates,andAPIs,reviewsandapprovesallqualityrelateddocuments.质量部门要确保关键偏差得到充分调查和处理。QUensuresthatc

3、riticaldeviationshavebeenfullyinvestigatedandresolved.质量部门审核、批准/拒收中间体和原料药的生产、包装过程，或者委托加工过程。QUreviewsandapproves/rejectsintermediatesandAPIsprocessed,packaged,orheldundercontractbyanothercompany.质量部门应建立合适的质量体系QUestablishesappropriatequalitysystems.质量部门负责审核和批准：QUisresponsiblefo

4、rreviewandapprovalof:原料药放行前应有完整的批生产记录和实验室控制记录；·CompletedbatchproductionandlabcontrolrecordspriortoAPIrelease所有标准和主生产工艺；·Allspecificationsandmasterproductioninstructions所有潜在影响原料药质量的程序（如sop）·Allprocedures(e.g.SOPs)potentiallyimpactingAPIquality验证方案和报告·Validationprotocolsandrepo

5、rts影响原料药质量的变更·ChangesimpactingAPIquality质量部门应确保：QUensuresthat:质量相关的投诉已经得到调查和处理；·Qualityrelatedcomplaintsareinvestigatedandresolved物料已经按要求测定并报告结果；·Materialsareappropriatelytestedandresultsarereported有用于关键设备的维护和校验的有效体系；·Effectivesystemsareusedformaintainingandcalibratingcritica

6、lequipment稳定性数据支持复验期和保存条件的制定；·Stabilitydataarecreatedtosupportretestdatesandstorageconditions按照经批准的计划定期进行内部审计；·Internalauditsareperformedregularlywithanapprovedschedule审计缺陷和纠正措施以书面形式报告并抄送相关责任部门负责人；·Auditfindingsandcorrectiveactionsaredocumentedandbroughttotheattentionofrespon

7、siblemanagement制定年度产品质量回顾报告·Productqualityreviews(preferredannually)areperformed配备充足的实验室设施用于物料、中间体和原料药的检测。.·Adequatelabfacilitiesareavailabletotestallmaterials,intermediatesandAPIs.质量部门可以将生产过程控制的测试和中间体放行的职责和权力授权给生产部门。QUmaydelegatetheresponsibilityforin-processtestingandreleas

8、eofintermediatestoproductionunit.C．生产部门职责根据书面程序起草、审核、批准和分发原料药生产指令。.P