CGMP文件_化学药品和溶剂的接收_保管和处理的标准操作.pdf

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1、文件编码Doc.No.:标准操作程颁发日期：生效日期：序IssueDate:EffectiveDate:Standard复审日期：Operating替代：Supersedes:ReviewDate:Procedure页码：第1页共8页PageNo.:1of8标题：化学药品和溶剂的接收，保管和处理标准操作程序TITLE:RECEIPT,MAINTENANCEANDHANDLINGOFCHEMICALSANDSOLVENT1.0目的Purpose:制定QC用于分析的化学药品和溶剂的接收，保管和处理程序。Laydownaprocedureforreceipt,handl

2、ingandmaintenanceofchemicalsandsolventsusedforanalysisinQualityControldepartment.2.0范围Scope:本程序适用于QC化学药品和溶剂的接收，保管和处理，同时也适用于实验室工作的安全。Thisprocedureisapplicableforreceipt,maintenanceandhandlingofallchemicalsandsolventsusedinQualityControldepartment,andalsoappliestothesafetyinlaboratorydu

3、ringworking.3.0定义Definitions:无Nil4.0责任Responsibility:所有QC人员有责任按照本程序的规定操作。AllQualityControlpersonnelareresponsibleforperformingtheactivityaspertheprocedure.5.0程序Procedure：5.1通则GeneralInstructions:5.1.1所有的化学药品只能从经授权的生产商和经销商那获得。Allchemicalsshouldbeprocuredonlyfromauthorizedmanufactureran

4、ddealer.5.1.2在需要的时候，要使用合适的安全防护用具，比如：面具，手套，安全护目镜，安全鞋。Useappropriatesafetyapplianceslikemask,handgloves,safetygogglesandsafetyshoeswherevernecessary.5.1.3在处理易燃性的溶剂时，要确保旁边有灭火器。Whilehandlingflammablesolvents,ensurethefireextinguisherisnearby.5.1.4所有的加热活动须在通风橱内进行。Allheatingactivitiesshould

5、becarriedoutinfumehood.5.1.5要仔细，小心地处理强酸和有毒物质。制定人审核人批准人PreparedbyReviewedbyApprovedby签名/日期Sign/Date名字Name职务Designation文件编码Doc.No.:PageNo.:2of8标题：化学药品和溶剂的接收，保管和处理标准运行程序TITLE:RECEIPT,MAINTENANCEANDHANDLINGOFCHEMICALSANDSOLVENTStrongacids,poisonousmaterialshouldbehandledwithcareandcaution

6、.5.1.6避免化学药品和溶剂和皮肤、眼睛直接接触。Avoidchemicalsandsolventsfromcomingincontactwithskinandeyes.5.1.7要用大量的冷水来冲洗溅在皮肤上的药品。Rinsesplashesofthesampleontheskinwithplentyofcoldwater.5.1.8如果腐蚀的物质伤到眼睛了，立刻用缓流的水冲洗眼睛，眼皮要睁大，不断转动眼睛，然后马上找眼科医生。Ifcorrosivesubstancesaffecttheeyes,rinsetheeyeswithagentlejetofwate

7、r.Holdtheeyelidswideopen,andmovetheeyesinalldirections.Consulttheeyespecialistimmediately.5.1.9不要把不兼容的化学药品放得太近。Donotkeepnon-compatiblechemicalsclosetoeachother.5.1.10所有的化学药品和溶剂都得按标签上的条件储存。Allchemicalsandsolventsshouldbestoredaspertheconditionmentionedonlabel.5.1.11使用完后，把化学药品和溶剂放在指定的地方

8、。Afte