GMP十项基本原则.docx

GMP十项基本原则.docx

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GMP十项基本原则

TENPRINCEPLEOFGMP

1.WritingStepByStepProceduresThatProvideaRoadmapForControlledandConsistentPerformance2

1.1.Introduction2

WhatAreWrittenProcedures?

2

WhyAreWrittenProceduresImportant?

3

2.CarefullyFollowingWrittenProceduresToPreventContaminations,Mixups,andErrors4

3.PromptlyandAccuratelyDocumentingWorkForComplianceandTraceability5

4.ProvingThatSystemsDoWhatTheyAreDesignedToDoByValidatingWork7

5.IntegratingProductivity,ProductQuality,andEmployeeSafetyIntotheDesignandConstructionofFacilitiesandEquipment9

6.ProperlyMaintainingFacilitiesandEquipment10

7.ClearlyDefining,Developing,andDemonstratingJobCompetence11

8.ProtectingProductsAgainstContaminationByMakingCleanlinessaDailyHabit13

9.BuildingQualityIntoProductsBySystematicallyControllingComponentsandProductRelatedProcessesSuchAsManufacturing,Packaging,andLabeling,Testing,Distribution,andMarketing14

10.ConductingPlannedandPeriodicAudits15

1.WritingStepByStepProceduresThatProvideaRoadmapForControlledandConsistentPerformance

1.1.Introduction

Itisestimatedthat90-95%ofallourdailyactivitiesarehabit.Ourdaysarefilledwitheatinghabits,workhabits,sleepinghabits,etc.Stopandthinkaboutitforamoment.compareyourdailyroutinefromonedaytothenext.Isitprettymuchthesame?

Doyoufollowthesameproceduresthroughouttheday?

Day-inandday-out?

It'snotsurprisingifyoudo,mostofusarecreaturesofhabit.

Ourlivesaregovernedbyprocedures.Forexample:

Whatisyour"procedure"whenyoufirstgetupinthemorning?

Doyouputonthecoffee?

Shower?

Dress?

Readthepaper?

What'syour"procedure"whenyoufirstarriveattheplant?

Yes,whetherwelikeitornot,ourlivesaregovernedbyprocedures.Themaindifferencebetweentheprocedureswefollowinourpersonallivesandtheprocedureswefollowatworkisthewordwritten.Becauseofthecriticalnatureofyourindustry,youcan'ttakeanychances.Youmustputyourproceduresinwriting.WrittenproceduresformthebackboneofyourbusinessoperationandarethekeytoGoodManufacturingPractice.

WhatAreWrittenProcedures?

Well,writtenproceduresareimportanttools,and,likeanytool,havevalueonlywhenproperlyused.Forexample,theblueprintsthatacarpenterfollowswhenbuildingahousearehiswrittenprocedures,hiscontrols.Ifhedoesn'tfollowhisblueprints,thefinishedhousewon'tturnoutasplanned.Likewise,yourwrittenproceduresprovideyouwithdetailedstep-by-stepinstructionsforexecutingorcontrollingtheimportantpartsofyourbusiness.Eachstepmustbewritteninaclearandlogicalsequence.Allstepsshouldleadtoourfinalgoal-asafeandeffectiveproduct.Anotherwayyoumightthinkofwrittenproceduresisasaroadmap,whichwhencarefullyfollowed,helpyouavoidwrongturns-wrongturnsthatcouldputyouontheroadtomix-ups,errors,andrecalls.

So,justasyoufrequentlycheckyourroadmaponatrip,tobesureyouareontherightroadandheadedintherightdirection,writtenproceduresneedtobecheckedregularlytostayontheroadtoquality.

WhyAreWrittenProceduresImportant?

Let'sexaminequicklywhywrittenproceduresaresoimportanttoyouroperations.Writtenproceduresservesiximportantfunctionsinyourcompany:

Standardsofperformance-Writtenproceduresareimportantinestablishingandenforcingworkstandards.Whererequired,writtenprocedureshelptoensurethatthesamejobisconsistentlyperformedthesamewayeachtime.

Instruction-Writtenprocedureshelpinstructemployeesatalllevelsofthecompany.Forexample,ifyouareanewemployeetryingtolearnthejob,oranexperiencedemployeeassignedtoadifferentjob,writtenproceduresserveasatrainingguideline.

Reference-Itisdifficulttoremembereverystepinvolvedinmanufacturingaqualityproduct.Writtenproceduresprovideatime-savingchecklistneededtomakesureeachstepiscarefullyfollowed.

Control-Writtenprocedures,whenwelldeveloped,haveimportantcontrolcharacteristics.Theytellyouwhattolookforwhenauditingandhowtoevaluateresultsforcompliance.

Review-Puttingyourproceduresdownonpaperprovidesyouwiththeopportunitytoseehowyoucanimproveyouroperationsandplanforperformanceimprovement.

Documentation-Finally,writtenproceduresarearecordofhowyoudocertainoperations.Theyarebasicbusinessdocumentswhicharecriticaltosuccess.Forexample,whenacomplaintisreceivedconcerningaproduct,writtenprocedureshelpdocumentwhathappenedandidentifypotentialcausesofthecomplaint.

Tips

Usethesehelpfulhintsfordevelopingwell-writtenproceduresandgettingthemfollowed:

OutlinetheJob.

Outliningthejobbeforeyoubeginwritingtheprocedurewillhelpyoutoapproachitinanorganizedfashion.Youcandothisbycreatingabriefbreakdownoftheimportantstepsandthekeypointstorememberwhenperformingthejob.

WriteFortheReader.

Besurethatyouuselanguagethatthereaderwillunderstand.Addtionally,youcanincreasethereadabilityoftheprocedurebyusingshort,simplesentences,usingfamiliar,strongandshortwords,andwritinginaconversationalstyle.

UsePicturesToPunctuate!

Apictureisworthathousandwords,anditisthereforeveryimportanttousepicturestopunctuateprocedures.Apicturecanbeanytypeofillustrationorexamplewhichclarifies,supports,orreinforcesthecriticalinformationinaprocedure.

PutProceduresInaPackage

Inretail,youcanhaveagreatproductatagreatprice,butifyoudon'tpackageandmerchandiseitproperly,itwon'tsell.Sellingwrittenprocedures（gettingemployeestofollowthem）isnodifferent.Theproceduresmaybewell-written,butunlessyoupackagetheminawaythatrelatestotheneedsofemployees,youwon'tgetthemfollowed.Payattentiontothefollowingthingswhenpackagingprocedures:

pagedesign,instructions,tableofcontents,index,dividers,visuallayout,andthetypeofbinderyouuse.

Summary

Writtenproceduresareessentialtotheconsistentfunctioningofyourcompany.Whenyouwritethem,makesurethattheyareclear,concise,easytounderstand,andlogical.Havingwellconceived,wellwritten,andwellpackagedproceduresisthefirststeptowardGMPcompliance,andcontrolledandconsistentperformance!

2.CarefullyFollowingWrittenProceduresToPreventContaminations,Mixups,andErrors

Howwouldyouanswerthisquestion-"WhatisthebestwaytoensurecompliancewiththeGoodManufacturingPracticeRegulation?

"Hopefully,youranswerwouldbe,"Bycarefullyfollowingeachstepofyourcompany'swrittenprocedures."

Why?

BecausetheheartofGMPistheestablishmentofwellwrittenproceduresforeachstepofourmanufacturingandqualityoperations.Thesewrittenproceduresprovidethecontrolsnecessarytominimizethechanceofmixupsanderrorsinthemanufactureofproducts.Whenyoucarefullyfollowwrittenprocedures,younotonlyensurecompliancewiththeGMPregulation,but,moreimportantly,youensuretheconsistentqualityofyourcompany'sproducts.

ShortcutsorDeviations

Sometimesitseemsthatthestepsdescribedbythewrittenproceduresarenotthemostefficientwaytodothejob.Ifyouareanexperiencedemployee,youmayseeshortcutsthatappeartosavethecompanytimeandmoneyormaymakeyourjobeasier.

Evenso,neverdeviatefromyourwrittenprocedurewithouttheapprovalofyoursupervisor.First,manyapparentshortcutshavepitfallsthatcanbecostlyinthelongrun.Second,eachstepinawellwrittenprocedurehasapurpose.Thismaynoteffectyoudirectlybutmaybethereasacheckorbalancetoanotherphaseoftheoperation.Onlythosedesignatedpersonswithaviewofthetotalprocesscanapproveshortcutsordeviationsinfollowingwrittenprocedures.

Ifyoudohaveanideaforimprovinganoperation,talktoyoursupervisor.Ifyourideasisagoodone,itshouldbecomepartofthewrittenproceduresothateveryonecanbenefit.

Summary

Thewrittenprocedureisthemostvaluabletoolthatyouhaveatyourdisposaltoensureproductquality.

Awrittenprocedureisawellthoughtoutplantohelpyouattaintheconsistentqualityinyourworkinwhichyoucantakepride.

Writtenproceduresareasimportanttotheexperiencedveteranastheyaretothenewlyhiredemployee.

ThewrittenprocedureisyourkeytoensurecompliancewiththeGoodManufacturingPracticeRegulations.

Remember,thenexttimesomebodyasksyou"what'sthebestwaytoinsurecompliancewiththeGMPregulations,youcananswer"bycarefullyfollowingeachstepofourcompany'swrittenprocedures."Writtenproceduresareyourroadmaptoquality.Don'ttakeashortcut!

3.PromptlyandAccuratelyDocumentingWorkForComplianceandTraceability

Arecordisadocumentthatrecallsorrelatespastevents.Itisabodyofknownfacts.TherecordsyourcompanykeepstocomplywiththeGMPregulationsconcernthepeople,theequipmentandthestep-by-stepprocessesofmanufacturingaqualityprocessesofmanufacturingaqualityproduct.Theserecordsprovideacompletehistoryofyourproductandprovideameansofevaluatingthesourceofanycomplaintsregardingyourproducts.

Therecordsyoukeeponthejobareliketherecordsdoctorskeepinahospital.Patientchartsrecordcurrentconditionandmedicalhistoryrecordsarereviewedtoensurequalityhealthcare.Theserecordsrelatetheexactactivitiesthatwereperformedonthepatient.Yourrecordsalsorelatetheexactstepsthatwerecompletedtomanufacturetheproduct.

AccurateRecordsAreImportant

Althoughitmayseemunnecessaryto