口服固体制剂工艺验证指南sop

《口服固体制剂工艺验证指南sop》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。

1、生效H期EffectiveDate:下次审核口期NextReviewDate:替代文件编号SupersedesDocumentNo.:职能Role部门Dept签名&日期Signature&Date文件发放部门及分发号DistributedDepartments&No.1•目的PURPOSE木程序旨在为口服固体制剂产品工艺验证提供指导，确保制剂产品的工艺验证过程符合相关注册法规和质量法规的要求。TheSOPisintendedtoprovideavalidationguidelinefortheOralSolidDosageFormstoensureallt

2、hevalidationcampaignsconformtorelatedregistrationstatuteandqualityrequirements.对于具有特姝工艺步骤及特性的产品或代加工(OEM)产品的工艺验证，可根据经验和可获得的某些产品资料(如产品技术转移报告)，设计特定的取样、检测和可接受标准，并在验证方案中给出科学的说明。Someprocesseshavespecificprocessstepsorprocesscharacteristicsorthecontractmanufacturingproduct(OEM),whichwill

3、requirespecialsampling,testingandacceptancecriteria.Basedonexperienceandavailableinformationwithacertainproduct(e.g.producttechnicaltransferreport),ascientificrationaleshallbedeclaredclearlyintheprotocoltomodifythesamplingplan,testingandacceptancecriteria.2•范围SCOPE本程序适用于***所有的片剂和胶

4、囊剂产品的工艺验证。包括新工艺的最初验证及随后的工艺改进验证(如原辅料、生产设备、生产工艺的变更)以及再验证。Thisguidelineappliestoalltabletsandcapsulesat****,includingtheinitialvalidationofnewprocesses,subsequentvalidationofmodifiedprocesses(e.g.rawmaterials,equipmentandprocesschange)andrevalidation.3.定义DEFINITIONS工艺验证ProcessValidat

5、ion证明特定的生产工艺能够始终如一地生产出符合预定的质量标准和质量特征产品的有文件证明的一系列活动。ProcessValidationistheestablishmentofdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductthatmeetspredeterminedspecificationsandqualitycharacteristics.前验证Prospectivevalidation在新产

6、品上市销售前或对产品特征有影响的生产工艺发生变更，进行的验证活动。Validationconductedpriortothedistributionofeitheranewproduct,oraproductmadeunderarevisedmanufacturingprocess,wheretherevisionsmayaffecttheproduct^attributes.同步验证ConcurrentValidation对于预先计划的产品上市与产品销售同步进行的验证。应具备相对常规检测而加强的取样和检测计划。Concurrentvalidationis

7、performedasapreplannedactivityonamarketedproductconcurrentlywithproductdisposition.Anintensifiedsamplingandtestingplanrelativetoroutinetestingshouldbeused.再验证Revalidation证实工艺过程的变化不对工艺特性及产品质量产生负面影响。Providestheevidencethatchangesinaprocessdonotadverselyaffectprocesscharacteristicsan

8、dproductquality.新产品NewProducts研发或