欧盟清洁验证方案(带风险分析)VIP免费

Subject/主题LovastatinTablets20mgCleaningValidationProtocol鲨鱼软骨片清洁验证方案文件编号：Tableofcontents目录1.Responsibility职责2.Purpose目的3.Frequency周期4.RelevantSOP’s相关的SOP’s5.Equipment设备6.TestMethod测试方法7.AcceptanceCriteria接受限度8.RiskAnalysis风险分析9.SamplingPlan抽样计划10.Actiontakenwhenout-of-limitresultfound对不符合接受限度的测试结果所采取的措施12.Revalidation再验证13.CleaningValidationExecutiveRecord清洁验证过程记录14.Conclusion结论Attachments附件Writtenby:制订者：Date:日期：Reviewedby:复核者：Date:日期：Approvedby:批准者：Date:日期：Approvedby:批准者：Date:日期：1.Responsibility职责QAisresponsibleforplanthecleaningvalidation.QA负责整个清洁验证的安排QCisresponsibleforsamplingandanalysis.QC负责抽样及测试ProductionDepartmentisresponsibleforperformingcleaningproductionequipment.生产部负责设备的清洁.2.Purpose目的ThepurposeofthiscleaningvalidationprotocolistodemonstratethatthecleaningprocedureusedtocleanJHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachinecaneffectivelyremoveresiduesoftheproductsmanufacturedinZS-650VortexOscillator/CompactSieve，JHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinetoapredeterminedlevelthatdoesnotraiseanysafetyconcerns.清洗验证方案的目的是证明JHZ-250B高效湿法制粒机、HLD-1000B型料斗式混合机清洁操作规程、CT-T-II型热风循环烘箱、JZF-400型整粒、粉碎机、KorschPH-300-36旋转式压片机、BGD-150D型高效包衣机和DPP-250B型多功能自动铝塑包装所使用的清洗程序能够有效地除去产品残留，达到预先确定的限度，从而达到对下批产品无影响。3.Frequency周期ThecleaningvalidationstudyisperformedafterthreeconsecutivemajorcleaningsofZS-650VortexOscillator/CompactSieve，JHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachineafterthemanufactureofLovastatinTablets.连续三批生产后，进行清洗验证研究。4.RelevantSOP’s相关的SOP’sSOP-PD-304-00CleaningprocedureforHLSG-300HighSpeedMixer/GranulatorHLSG-300型高效湿法混合制粒机清洁操作规程SOP-PD-304-00CleaningprocedureforLF120E-Bairpillow-dryGranulatorLF120E-B型沸腾干燥制粒机清洁操作规程SOP-PD-310-00CleaningprocedureforZP43HighSpeedrotarytabletpress高效ZP43旋转式压片机清洁操作规程SOP-PD-307-00CleaningprocedureforHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机清洁操作规程SOP-PD-306-00CleaningprocedureforYK-160granulatorsYK-160整粒机清洁操作规程SOP-PD-311-00CleaningprocedureforBG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机清洁操作规程SOP-PD-313-00CleaningprocedureforDPH-130、DPP-250BblisterpackagingmachineDPH-130、DPP-250型铝塑袍罩包装机清洁操作规程ESS-VD007Validationguideline–cleaning验证指南－清洁验证ESS-VD011Surfacesamplingforcleaningvalidation清洗验证设备表面取样ESS-VD014Selectionoftheworstcaseincleaningvalidation清洁验证中最坏情况的选择SOP-QC-1075检验操作规程ESS-GM066MicrobeTest微生物限度检测法5.Equipments设备5.1ListofEquipment设备清单ThelistofEquipmentusedinthemanufactureofLovastatinTablets:有关鲨鱼软骨片生产线的所有机器列出如下：1...