《变更评估项目表》word版

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1、项目号评估项目ItemNo.AssessmentItemA标准方法（原料，成品和包材）SpecsMethods(Rawmaterials-Finishedproducts-PackagingMaterials)A.1人员PeopleA.1.1实施培训TrainingA.2文件DocumentsA.2.1影响对规程/内控标准Impactonprocedures/in-housespecificationA.2.2新质量标准的合理性说明Justificationofnewspecification(s)A.

2、2.3需微生物评估MicrobiologicalassessmentA.2.4文件的传送／接收Impactontransferdocumentsreceived/sentA.2.5影响取样原则和方案ImpactonsamplinginstructionsA.2.6需供应商批准和签字确认Approval&SignoffbysupplierA.3实验室设备LabequipmentA.3.1需要新设备NewequipmentA.3.2(新)设备验证／校验(New)equipmenttobequalified/

3、calibratedA.4分析AnalyticsA.4.1影响当地方法的开发/验证/确认Impactonlocalmethoddevelopment/validation/verificationA.4.2影响当地方法的等同性(相对于法规/供户方法)Impactonlocalmethodequivalence(versusregulatory/suppliermethod)A.4.3影响批次整体考察ImpactonbatchoverviewA.4.4影响方法传送Impactonmethodtransfe

4、rA.4.5影响免检ImpactonreducedtestingA.4.6影响对照品ImpactonreferencestandardsA.5体系SystemA.5.1需要新的或更新稳定性研究NeworupdateofstabilitystudyrequiredA.6物流LogisticsA.6.1影响当地相关产品ImpactonlocallyrelatedproductsA.6.2需告知购买／配送NeedtoinformPurchasingand/orsuppliersand/ordistributi

5、onA.6.3需提供质量标准给供应商SpecificationneededbetransferredtosupplierA.6.4需要新的或升级质量协议New(orupdate)QualityAgreementA.6.5需要更改已处理的订单ChangeapplicabletoordersalreadyinprogressA.6.6影响库存ImpactonstockA.6.7限制产品的配送RestrictionstoproductdistributionA.8法规RegulatoryA.8.1与当地的法规

6、文件符合性ImpactonlocalregulatoryspecificationdocumentsA.8.2需要在当地政府机关备案NeedforlocalfilingA.8.3等待批准后才实施ImplementationwaitforapprovalB合同方／供应商／物料（原料,包材,成品）Contractor/Supplier/Material(RawMaterials-PackagingMaterials-FinishedProducts)B.1人员PeopleB.1.1实施培训TrainingB

7、.2文件DocumentsB.2.1影响当地的内部标准文件Impactonlocalin-housespecificationdocumentsB.2.2需要批准供应商所签署的标准文件ApprovalsignoffonspecificationdocumentsbysupplierB.2.3变更包装形式ChangetopackagingtypeB.2.4影响贮存条件ImpactonstorageconditionsB.2.5影响取样ImpactonsamplingB.2.6需更新（通常的）交货条件Upd

8、ateo(general)deliveryconditionsB.2.7影响合格供应商清单ImpactonapprovedvendorlistB.2.8影响包装工艺ImpactonpackaginginstructionsB.2.9影响当地法规中所描述的制造方法ImpactonmanufacturingmethoddescriptioninlocalregulatoryFilesB.3实验室设备LabEquipmentB.3.1需要新设备N