中药制剂管理与检验.pdfVIP

TraditionalChineseMedicine

DispensingUnit13

一、A1

1.Storepharmaceuticalpreparationsuntil

theexpirationdate

A.0

yearsB.

1yearC.

2years

D.3

yearsE.

4years

2.Whatisincorrectabouttheworkingsystemofthedrug

testingroom?

A.Equipfull-timetechnicalpersonneltoberesponsiblefor

inspectionB.Haveasoundsetofinspectionoperating

proceduresandqualitystandardsC.Inspectionreports

shouldbetimelyandaccurateD.Inspectionrecordscanbe

altered,butthereshouldbenotracesofalterationE.Original

recordsshouldbekeptfor3years

3.Alltheoriginalinspectionrecordsandinspectionreportsofthedruginspectionroomshallbe

boundintoabookaccordingtothebatchnumberandkept.

A.7

yearsB.

6years

C.5

yearsD.

3years

E.2

years

4.Oneoftheerrorsindescribingtheresponsibilitiesof

druginspectorsis

A.Accurate,reliable,andeasy-to-operatemethodsshouldbeusedforinspectionmethods.B.

Doyourjobwellundertheleadershipofthedirectorofthedrugtestingoffice.C.Youshould

haveacomprehensiveunderstandingofthequalityofpharmaceuticalpreparations.D.

Inspectionrecordsshouldbecorrectlywritten,signed,andsealed,boundintoavolumeonan

annualbasis,andkeptfor3years.E.Conductinspectionsstrictlyinaccordancewithnational

standardsatwork.

5.Thewrongwaytoinspectunqualifiedpreparationsis

A.NotforclinicaluseB.Analyzethe

reasonsforfailureC.In-depthand

practicalunderstandingoftheprocess

operationprocessD.Canbeusedfor

clinicaluseE.Compositetechnology

whennecessary

6.Whichstatementaboutthedrugtesting

roomisincorrect?

A.Responsibleforthesupervision

ofdrugqualityB.Inspectionof

preparationsinthepreparation

roomC.Canbeco-locatedwiththe

prepara