欧盟清洁验证方案

《欧盟清洁验证方案》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.Actiontakenwhenou

2、t-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lQAisresponsibleforplanth

3、ecleaningvalidation.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Thepurposeofthiscleaningvalidationprotocolistodemonstratethatthecleaningprocedureusedt

4、ocleanJHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinecaneffectivelyremoveresiduesoftheproductsmanufacture

5、dinZS-650VortexOscillator/CompactSieve，JHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinetoapredeterminedlev

6、elthatdoesnotraiseanysafetyconcerns.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Thecleaningvalidationstudyisperforme

7、dafterthreeconsecutivemajorcleaningsofZS-650VortexOscillator/CompactSieve，JHZ-250Bhighshearmixer/granulator,three－dimensionalmixer，CT-C-2HotAirCirculatingDrier，JZF-400granulators&millKorschPH300-36TabletPress，BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblister

8、packagingmachineafterthemanufactureofLovastatinTablets.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/G