Good Warehousing Practices

Good Warehousing Practices

1. GOOD WAREHOUSE
PRACTICES
Dr. K. VENKATESWARA RAJU
SHRI VISHNU COLLEGE OF PHARMACY
[email protected]

2. 2
GOOD WAREHOUSE PRACTICES
1.Premises
2.Security
3.Temperature and humidity control
4.Equipment
5.Personnel
6.Sanitation
7.Receipt of incoming goods
8.Assembling orders and issuing goods(Warehousing of
FG and Dispatch of FG)
9.Packing for transportation
10. Transport

3. 3
PREMISES
Premises should be of suitable size and construction to facilitate cleaning, maintenance and orderly,
segregated storage
Storage areas must be designed to provide adequate:
-lightening,
-ventilation,
-temperature,
-sanitation,
-humidity,
-space,
-equipment,
-security conditions
Medicinal products should be stored separate from other goods to avoid the risk of cross contamination
Incoming goods should be physically or electronically separated from goods awaiting distribution until
approved by the responsible person
A segregated area must be provided for the holding and storage ofreturned and rejectedgoods prior to a
decision on further action
A secure, segregated area must be provided for the storage of controlled drugs
A separate, designed area should be provided for the assembly of customer orders

4. 4
SECURITY
Storageareasshouldbeprovidedwithsecuritytopreventtheftor
unauthorisedentry
Maintainacontrolofwhomayenterthefacilities
Establishsystemforcontrollingaccesstothefacility(includingall
entrancesandexits)

5. 5
TEMPERATURE AND HUMIDITY CONTROL
Alldrugproductsmustbestoredatappropriateconditionsasstatedonthelabelofthe
product
Thetemperatureofallstorageareasshouldberegularlymonitored.
Controlledtemperaturestorageareasshouldbeequippedwithrecordersanddevices
whichindicatewhenthespecifictemperaturerangehasnotbeenmaintained.
AwrittenproceduremustspecifytheactiontobetakenwhenthisoccursControlshould
beadequatetoensurethatallpartsofthestorageareaarekeptwithinthespecified
temperaturerange
Shouldalwaysbeabackupsystemincasemainsystemfails
Thehumidityofallstorageareasshouldberegularlymonitoredusingrecordersand
deviceswhichdocumentthehumiditymeasures
Iftheproductspecrequireaspecifichumidity,awrittenproceduremustspecifythe
actiontobetakenwhenthespecifiedhumidityrangehasnotbeenmaintained.
Establishanormaloperatingbaselineofhumidityifnospecificvalueisrequired
Recordsoftemperatureandhumidityinallstorageareasshouldbereviewedand
retainedbyadesignatedresponsibleperson

6. 6
EQUIPMENTS
Thereshouldbeaplannedpreventativemaintenanceprogram
inplace.
Recordingandcontrolequipmentshouldbecalibratedand
checkedatdefinedintervalsbyappropriatemethods
Alarmset-pointsshouldbecheckedonperiodicintervals
Computerizedsystemusedforstockcontrol/distributionshould
bevalidated

7. 7
PERSONNEL
Theorganisationchartshouldbeinplace
Thereshouldbeasufficientnumberofstaff
Thereshouldbeclearlydefinedjobdescription
Personnelshouldbetrainedinrelationtogoodstorage
anddistributionpracticeandtothedutiesassignedto
them
Thecurrentrecordsoftrainingshouldbeinplace
Thetrainersshouldhaveestablishedandapproved
qualification

8. 8
SANITATION
Awrittensanitationprogramshouldbeinplaceindicatingthe
frequencyandmethodofcleaningthefacility
Storageareasshouldbecleanedandaccumulatedwasteremovedat
regularintervals
Apestcontrolprogramshouldbeinplace
Smoking,eatinganddrinkingshouldbepermittedonlyinsegregated
areas,andnotinthoseareasusedforthestorageandhandlingoffinal
drugproduct
Spillsinvolvingdrugproductsmustbepromptlycleaned-upand
renderedsafeinaccordancewiththerelevanthealthandsafety
requirementsfortheproduct
Adequatetoiletandchangingfacilitiesshouldbeprovided,andthey
shouldbesegregatedfromthemainstorageandorderassemblyareas

9. 9
RECEIPT OF INCOMING GOODS
shouldbecarriedoutaccordingtoapprovedadequatesop
visuallyexamineforidentityagainsttherelevantsupplier’s
documentation
visuallyexaminefordamage
sub-divideaccordingtobatchnumbersifmorethanonebatch
rejectproductifdamageorotherwiseunfitforuse
handlehighsecuritymaterials(controldrug,highvalueitems,
productsrequiringaspecificstoragetemperature)
confirmwithsignaturethatreceivinggoodsareasspecifiedby
supplierorifnotprovideadequatecomments

10. 10
ASSEMBLING ORDERS AND ISSUING GOODS
ShouldbecarriedoutaccordingtoapprovedadequateSOP
Pickupgoodsaccordingtoformaldispatchdocuments
Assemblecompleteorder
Visuallyexamineforidentityandcompleteness
Visuallyexaminefordamage
Confirmwithsignatureproperlyassembledorder
Prepareadequateshippingpackagetoprotectanydamageof
goods,sealpackandproviderelevantidentification
Theheatsensitivedrugsifnottransportedbyappropriate
specializedmeansshouldbeprovidedisolatedpacking

11. 11
PACKING FOR TRANSPORTATION
Productsshouldbepackedinsuchawaythat:
theidentificationoftheproductisnotlost,
theproductdoesnotcontaminateandisnotcontaminatedby
otherproductsormaterials
adequateprecautionsaretakenagainstspillageandbreakage
productsrequiringcontrolledtemperaturestorageshouldbe
providedwithinsulatedpacks
thereshouldbeinplacedocumentedevidencethattheinsulated
packsensuredadequatetransportconditionswithregardsto:
-productquantity
-ambienttemperature
-maximumdeliverytime.

12. 12
TRANSPORT
Productsshouldbetransportedinsuchawaythat:
Thesafety,identity,strength,qualityandpurityoftheproductisnotlost
Theproductisnotcontaminatedbyotherproductsormaterials
Adequateprecautionsaretakenagainstspillageorbreakage
Theproductanditspackagearenotsubjectedtounacceptabledegreesof
heat,cold,light,moistureorotheradverseinfluencesnortoattackby
micro-organismsorpests
Drugproductsrequiringcontrolledtemperaturestoragebyappropriate
specializedmeansorshouldbepackedwithadequateinsulation
Documentsshouldbeprovidedtocoverallshipments.Thesedocument
shouldincludeasminimum:
•nameoftheproduct
•quantityoftheproduct
•specialstorageandhandlinginstructions

13. 13
RECORDS
FOLLOWING RECORDS SHOULD BE IN PLACE:
RECEIVING GOODS
ISSUING GOODS
TRAINING
MONITORING TEMPERATURE AND HUMIDITY
CLEANING OPERATION
PEST CONTROL
CALIBRATION
PREVENTATIVE MAINTENANCE
RECALL
COMPLAINTS
INVENTORY
LOG OF SIGNATURE

14. 14
REFERENCES
http://pharmastoremanagement.blogspot.com/2009/06/good-
warehousing-and-distribution.html