欧盟工艺验证报告(中英文翻译)

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1、BAFNAPHARMACEUTICALSLIMITEDPage1of35PROCESSVALIDATIONSUMMARYREPORTDocNo.:PVSR:B08005/0.5M/00ProductParacetamoltablets500mgRef.ProtocolNo.:PVP:B08005/0.5M/00PROCESSVALIDATIONSUMMARYREPORT工艺验证总结报告FORMANUFACTURINGPROCESSOFParacetamoltablets500mg对乙酰氨基酚500mg片生产工艺B

2、AFNAPHARMACEUTICALSLIMTEDPage2of35PROCESSVALIDATIONSUMMARYREPORTDocNo.:PVSR:B08005/0.5M/00ProductParacetamoltablets500mgRef.ProtocolNo.:PVP:B08005/0.5M/00Thelistedreviewandapprovalsignaturesindicatetheapprovalofthevalidationresults.以下审核和批准签字表示批准验证结果。VALIDATIO

3、NREPORTAPPROVAL验证报告批准ActivityNameDesignationDepartment部Signature签Date日活动姓名职务门字期PreparedQualityPRAKASH.K.CExecutive主ByAssurance制管QA定ReviewedAMARESH.CManager经理Production生By产审核ReviewedQualityRAVICHANDRAN.N.RManager经理ByControl质控审核ReviewedGeneralJAYANTHA.TTechnica

4、l技ByManager总经术审理核ReviewedDeputyQualityRAGHAVENDRAN.VByManager副经Assurance审理QA核ApprovedQualityDHAYALASEKARM.NManager经理ByAssurance批QA准BAFNAPHARMACEUTICALSLIMTEDPage3of35PROCESSVALIDATIONSUMMARYREPORTDocNo.:PVSR:B08005/0.5M/00ProductParacetamoltablets500mgRef.Pro

5、tocolNo.:PVP:B08005/0.5M/00INDEXFORMATPAGENO.NO.OFPAGESProcessvalidationSummaryreportcoversheet.工艺验证总结报告封面页11ValidationReportApproval验证报告批准21Index引言31Introduction简介41References参考41BatchReferences批参考41ValidationofDrymixingandGranulation干混和制粒确证5-62ValidationofD

6、ryingProcess干燥过程确证71ValidationofBlendingProcess混合过程确证8-103ValidationofLubricationProcess润滑过程确证11-144ValidationofCompressionProcess压缩过程确证15-2410WorstcasestudyofTabletHardness硬度最差情况研究25-262Impactstudyofpowerfailureincompressionprocess压片过程电力故障影响研究27-282Compariso

7、nofinprocessresultswithqualitycontrolresults质量控制的过程比较结291果EndofcompressionresultsasperFinishedProductSpecification压片结束结果30–334Rejectclassification不合格分类341Validationfinalconclusion确证最后结论351BAFNAPHARMACEUTICALSLIMTEDPage4of35PROCESSVALIDATIONSUMMARYREPORTDocNo.

8、:PVSR:B08005/0.5M/00ProductParacetamoltablets500mgRef.ProtocolNo.:PVP:B08005/0.5M/001.0INTRODUCTION简介ThisreportsummarizestheresultsofprocessvalidationperformedforBatchNo.907001,907002,and