固体制剂清洁验证方案.docx

固体制剂清洁验证方案

文件编号

固体车间清洁验证方案

CleaningvalidationMasterPlanforSolidDosageWorkshop

立项部门:质量保证部

InitiationDepartment:QualityAssuranceDepartment工艺验证小组负责

人:

Leaderofvalidationteem:方案制订日期:年月日Date:YearMonthDay

-1-

目录

ListofContent

.验证概述一

OVERVIEWOFVALIDATION

二.验证组织机构及人员安排VALIDATIONORGANIZAGIONANDMEMBERS

三.应用范围

AREASOFAPPLICATION

四.风险评估RISKEVALUATION

五验证方案表格

VALIDATIONMATRIX

六清洁溶剂CLEANSINGAGENTS

七.可接受标准的确定ACCEPTANCECRITERIA

八.清洁验证取样

CLEANINGVALIATIONANDSAMPLING

九清洁验证的实施

IMPLEMENTATIONOFCLEANINGVALIDATION

十.偏差、变更DEVIATIONSANDCHANGES

十一.再验证RE-VALIDATION

第2页共36页

一.验证概述OverviewofValidation

1.验证目的

根据GMP的要求，在口服固体制剂生产结束后，要对生产设备及操作间进行彻底清洁，以避免造成不

同批号或不同品种产品之间的污染和交叉污染。根据各生产设备的《操作、清洁及维护保养》标准操作

规程，进行风险分析，选出最坏情况产品。为了验证清洁方法的稳定性与可靠性，对所选的最坏产品进

行三次清洁验证。每批产品生产结束后，对所有在生产中使用的生产设备及容器具进行清洁，清洁后取

样检测化学残留及微生物残留，要求残留量低于设定的残留限度要求。AccordingtorequirementsofGMP,themanufacturingequipmentsand

roomsmustbecompletely

cleanedtoavoidcontaminationofdifferentbatchesofsameproductsorcross-contaminationof

differentproductsaftermanufacturingoforalsoliddosage.Therearetwotypesofcleaningmethod

basedonSOPsofOperation/Cleaningandmaintenanceforindividualequipments:implementthe

riskanalysisassessmenttochoosetheworstcaseproducts.Threeconsecutivecleaningvalidation

willbeconductedtovalidatethestabilityandreliabilityofcleaningmethod.Allequipmentsand

utensilsusedinmanufacturingmustbecompletelycleanedonceeverybatchoftheworstcase

productsarefinished,thensampletotestchemicalresidualandmicrobialresidual,therequirement

isthelevelofresidualislessthanthelimitofresidual..

二.验证组织机构及人员安排ValidationOrganizationandTeamMembers

制造部/ProductionDept.组织清洁验证方案及报告的起草;

Preparethecleaningvalidationprotocol/report确定设备表面积、清洁方法、取样部位;

Determinethesurfaceareaofequipments,cleaningmethodandsamplinglocations

制定清洁操作规程;

Establishcleaningprocedure

按清洁操作规程清洁设备和容器具;

Cl