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ID:50243250
大小:881.00 KB
页数:126页
时间:2020-03-07
《欧盟清洁验证方案.doc》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、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-limit
2、resultfound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:126/1261.Responsibility职责lQAisresponsibleforplanthecleaningvali
3、dation.QA负责整个清洁验证的安排lQCisresponsibleforsamplingandanalysis.QC负责抽样及测试lProductionDepartmentisresponsibleforperformingcleaningproductionequipment.生产部负责设备的清洁.2.Purpose目的ThepurposeofthiscleaningvalidationprotocolistodemonstratethatthecleaningprocedureusedtocleanJHZ-250Bhighshear
4、mixer/granulator,three-dimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators126/126&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachinecaneffectivelyremoveresiduesoftheproductsmanufacturedinZS-650VortexOscillator/
5、CompactSieve,JHZ-250Bhighshearmixer/granulator,three-dimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinetoapredeterminedlevelthatdoesnotraiseanysafetyconcerns.
6、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126/126ThecleaningvalidationstudyisperformedafterthreeconsecutivemajorcleaningsofZ
7、S-650VortexOscillator/CompactSieve,JHZ-250Bhighshearmixer/granulator,three-dimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachineafterthemanufactureofLovastatinTa
8、blets.连续三批生产后,进行清洗验证研究。4.RelevantSOP’s相关的SOP’sSOP-PD-304-00CleaningprocedureforHLS
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