Goods manufacturing process on factories

GMP

1. Good Manufacturing Practices
(GMP)
Dr Narendra Nayak
Department of LPT, College of Veterinary
Sc.& A.H., Mhow

2. Guidelines for Good Manufacturing
Practices (GMP
Employeesworkinginafoodplantare
requiredtowashtheirhandswithasanitizing
soappriortobeginningorreturningtohandling
offood.
Loosehairposesserioussanitationproblems
intheplant.Therefore,allpersonsworkingor
visitingtheproductionareamustwear
authorizedheadcoveringtoavoidcontactof
loosehairwithfoodproduct.

3. Sanitaryprecautionsarerequiredtobetakenby
employeeswhensneezingorcoughing.An
employeewithinfectiousskineruption,
communicablediseaseorotherinfected
conditionsmusthaveplantmanagement
clearancebeforeallowedtohandlefood.
Employeesinproductionareasshouldwear
cleanuniforms.Theuniformsshouldbechanged
dailyorsoonerifsoiledforanyreason.Shirtsare
requiredtobebuttonedandtuckedintotrousers.

4. Workersintheproductionareawillnotwear
rings,andneck/earjewellery.Thispracticewill
precludemix-upoftheforeignmaterialsin
food.Watches,pens,pencilsandloose
materialsshouldberemovedpriortoentryto
productionareas.
Smoking,spittingorchewingoftobaccois
prohibitedintheproductionaswellasstorage
areas.

5. Consumptionofbeverageorfoodisallowed
exclusivelyinthedesignatedarea.
Nailpolishand/orperfumeisnotallowedin
productionorstorageareas.
Containersandequipmentmadeofglass,
includingglassthermometers,shouldnotbe
permittedintheproductionarea.
Goodhousekeepingintheproductionareais
necessaryforworkefficiencyandworkers'
safety.

6. Personnel
Thewearingofalltypesofjewellery(i.e.
earrings,watches,rings,neckchains,etc.)is
strictlyprohibitedinallplantoperatingareas.
Theonlyexceptionstothisruleareawedding
ringwithoutsetsandamedicalalert
necklace/bracelet,whichmustbewornunder
theappropriateoutergarment.

7. Washanddryhandsthoroughlybefore
startingworkandaftereachabsencefrom
the
workarea.Allpersonsmustwashanddry
theirhandsaftervisitingrestrooms,eating,
smoking,and/oranyothertimeswhenhands
havebecomesoiledorcontaminated.

8. Hairstylesonallemployeesshallbeofanature
thattheyappearneat,trimmedorfullyrestrained
toadegreethatwouldgiveaneat,cleanand
sanitaryappearanceasbecomingafoodplant.
Hairandbeardrestraintsarerequired
throughoutprocessingareas.Theserestraints
mustbeBerkeyCreameryissuedand
completelycoveremployee’shairandbeard.
Appropriatehaircoveringshallbeofatight
meshandbeworninsuchamannerasto
contain

9. Exposed, unwrapped product, as well as packaging
materials and equipment which
contacts exposed product shall not be handled with:
1. Injured or bandaged hands unless protected by
gloves. Gloves must be
maintained in an intact, clean and sanitary
condition, and changed frequently.
2. Cuts and open sores on fingers unless they are
covered by a band-aid with a finger
cot or glove.

10. Avoiduseofhandswhichmayresultincontaminationof
foodproducts.Suchpractices
include:
1.Touchingoftheface,adjustingglasses,wipingforehead,
placingfingersonorinmouth,noseorears.
2.Scratchingtheheadorbody
3.Handlingproductsfortastetestinginanunsanitary
manner.
4.Reachingintoicecreamingredientcontainersand
consumingpiecesofcookies,candies,nutmeats,etc.

11. Goodhygienemustbepracticedatalltimes.
Chewingtobacco,trimmingfingernails,
spitting,useofsnuff,chewinggumandopen
blowingofthenoseintheproductionareaor
anyareaexposedtoproductsorpackaging
materialsareexamplesofpoorhygiene
whichproduceunsanitaryandundesirable
conditions.

12. Smokingandtobaccousageofanytypearenot
permittedinanyareaofthefacility.
Smokingispermittedindesignatedareasonly
andemployeesmustwashtheirhandsbefore
returningtotheprocessingarea.
Employeesshallnotholdtoothpicks,
matchsticks,orsimilarobjectsintheirmouth
whileperformingtheirassignedduties.Pencils
orotherobjectsheldbehindtheearsare
forbidden.

13. Anypersonwho,bymedicalexaminationor
supervisoryobservation,isshowntohave,orappears
tohave,anillness,openlesions(includingboils,sores,
orinfectedwounds),oranyotherabnormalsourceof
microbialcontaminationbywhichthereisareasonable
possibilityofproduct,productcontactsurfacesor
productpackagingmaterialsbecomingcontaminated,
willbeexcludedfromanyoperationswhichmayresult
insuchcontaminationuntiltheconditioniscorrected.
Personnelareinstructedtoreportanysuchhealth
conditionstotheirsupervisor.

14. Clothing
Bearissueduniformsmustbeworninall
operatingareas.Shirtsshouldbecompletely
buttonedtothenexttothelastbuttonfromthe
toptoensurethatnotorsobodyhairisexposed.
Onlylongpants(i.e.belowthebottomofthe
calf)arepermittedintheplant.Shortsarenot
permitted.Officeanlaboratorypersonnelthat
spendmorethan5%ofaworkdayinthe
processingareamustbecoveredbyalabcoat.

15. Safetyglasses,goggles,orshieldsmustbe
wornwhenhandlinghazardousmaterials(i.e.
cleaningchemicals,petroleumproducts,etc.).
Eyewashandemergencyshowerfacilitiesare
availableforusewhennecessary.
Allexteriordoorsthroughouttheplantmust
remainclosedatalltimes.Theymustbeself-
closingandtightfitting.Itisnotpermissibleto
propdoorsopen,allowingdirt,insects,and
othercontaminantstoenter.

16. Storage and Handling of
Ingredients and Products
Storeallitemsofftheflooronpallets,slip-
sheetsorracksexceptwhereotherstorageis
authorizedbymanagementpersonnel.
Donotusedirtyorbrokenpallets.Remove
damagedpalletsforrepair.Storepalletsin
areasfreefromextraneousmattersuchasbird,
insectandrodentcontamination.Palletsstored
outsidearetobecleanedandsanitizedpriorto
use.Plasticpalletsareforuseintheprocessing
areaonly.

17. Process and Product Integrity
Vigilanceandgoodjudgmentmustprevailatall
timestopreventproductcontamination.Ifpresent,
stripoutercoveringsoffingredientcontainersprior
touse.Sealandidentifycontentsofpartiallyused
ingredientcontainers.Thesematerialsshouldbe
usedassoonaspossible.Removethelabelsfrom
emptyingredientcontainersandstorethemcovered
orinvertedoffthefloor.Coverandsealpartially
usedpackagingmaterialwhennotinuse.
Packagingmaterialmaynotbeusedforanything
otherthanproduct.

18. Sanitation
Sanitationstandardoperatingprocedures
(SSOP’s)mustbeinplaceandstrictlyfollowed
toassureproductintegrity.SSOP’s,with
documentation,include,butarenotlimitedto;
cleaning,gasket,o-ring,andcheck-valve
replacements,chemicaltitration,traininglogs,
etc.

19. Awrittencolour-codedbrush/bucketprogramisin
placeandmustbefollowed.
Washanddryhandsthoroughlybeforestartingwork
andaftereachabsencefromtheworkarea.Sanitize
handsfrequentlyindesignatedareas.Donotuse
equipmentaidswithwoodenhandles.Material
handlingequipment(i.e.scoops,carts,lifts,etc.)
mustbekeptclean,coveredandwellmaintained.
Followallcleaningproceduresexplicitly.Eye
protection(i.e.safetyglasses,goggles,orshield)
mustbewornwhenhandlingchemicals.

20. Equipmentmustbethoroughlycleanedaftereachuse
andatleastonceeachdayused(materialinstorage
tankscanbeheldfornolongerthan72hours).All
equipmentmustbeinspectedpriortoreassembly.
Cleanandreplaceproductcontactgasketsas
necessary.Clean,sterilizedscreensmustbeplaced
onfillerseachtimethefillerisused.Avoidexcessive
useoflubricantsonequipmenttopreventproduct
contamination.Alllubricantsmustbefoodgrade.
Lubricantsmustbestoredinnon-productionareas
whennotinuse.

21. Allcleaningequipment(i.e.cleaningaids,personal
protectiveequipment,chemicals,etc.)mustbestored
innon-productionareaswhennotinuse.Store
production-cleaningequipmentseparatefromfloor
cleaningequipment.Equipmentusedforcleaning
drainsshouldbeseparate,properlyidentified,and
storedinanisolatedarea.Floordrainsshouldbefree
ofalldebriswithnoevidenceofanyoffensiveodors.
Alldrainsmustbecleanedandsanitizedonaregular
basis.Onlyblackbristlebrushesmaybeusedto
cleanfloordrains

22. Record Keeping
Processingrecordsaremaintainedand
continuallymonitored.Identifyandsignall
temperaturecontrolcharts.Highlightandexplain
anydeviationsand/orabnormalitiesonthechart.
Mistakesmustbeinitialledandcrossedthrough
withasingleline.Donoteraseorattempttouse
whiteout.Lotidentificationnumberofallraw
materialsmustberecordedonbatchsheetsto
enabletracingoffinishedgoodsfromreceivingto
production,packaginganddistribution.

23. Quality Control
BonnieFordmaintainsfinaldecision-making
authorityinallmatterspertainingtoquality.
Productsofquestionablequalitywillbered-
taggeduntilfurthertestingiscompleted.Our
processorsandlaboratorydirectorare
responsibleforproperrecordkeeping.Alldata
shouldberecordedininkandclearlylegible.
Recordsarestoredinthelaboratory.

24. Maintenance
Theexteriorofthebuildingmustbeingoodrepair.
Maintainbuildingareasandequipmentinasanitary
condition.Buildinggrounds(i.e.weedcontrol,litter
removal,etc.)mustbeproperlymaintainedatall
times.Thebuildingshouldbeinsectandbirdproof
withtightfitting,self-closingdoors.Theremaybeno
cracksorholesinthebuildingstructurewherepests
couldenter.Screenwindowopeningstoprevent
entranceofpests.Maintaintherequired18”open
floorareaforrodentcontrolwithapaintedstripeor
angleiron.

25. Utilities
Facilityisequippedwithadequateventilationto
circulateclean,freshairthroughouttheplant.Steam
introducedintoproductorcomingincontactwithfood
surfacesmustbeculinarygrade.Providewaterata
suitabletemperatureandundergoodpressurefor
utensilcleaningandequipmentsanitation.Waterused
insanitation,cleaning,oranyotherpurposethatcomes
incontactwithfoodsurfacesmustbepotableandof
sanitaryquality.Ensurethatproperbackflow
preventiondevicesexistbetweensystemscarrying
waterforprocessing,wastewaterandCIPcircuits.

26. Visitor Rules
Visitors,aswellasregulatorypersonnelmustadhere
toallplantrulesandcomplywithsanitationand
safetyregulations.Authorizedpersonneladmittedto
processingareasshallconformtothesamerules
and/orregulationsasoperationspersonnel.Ifan
exceptionappearstobenecessary,thelaboratory
directorormanagershallbecontactedforproper
clearance.Visitorsunabletoremovejewelledrings
shallweartapeandarubbergloveovertheringasa
protectiverestraint.Allcontractorsworkinginthe
plantmustcomplywithGMPpolicies.

27. THANK YOU