Good manufacturing practice (gmp)

“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.

1. Good Manufacturing Practice (GMP)
By
SURYAKANT VERMA
Assistant Professor,
Department ofPharmaceutics,

2. Good Manufacturing Practice (GMP)
“AGMPisasystemforensuringthatproductsare
consistentlyproducedandcontrolledaccordingtoquality
standards.Itisdesignedtominimizetherisksinvolvedin
anypharmaceuticalproductionthatcannotbe
eliminatedthroughtestingthefinalproduct”.
GMPcoversallaspectsofproductionfromthestarting
materials,premisesandequipmenttothetrainingand
personalhygieneofstaff.Detailed,writtenproceduresare
essentialforeachprocessthatcouldaffectthequalityof
thefinishedproduct.Theremustbesystemstoprovide
documentedproofthatcorrectproceduresare
consistentlyfollowedateachstepinthemanufacturing
process-everytimeaproductismade.

3. COMPONENTS OF GMP
GMPrequiresthatthemanufacturingprocessis
fullydefinedbeforebeinginitiatedandallthe
necessaryfacilitiesareprovided.Inpractice,
personnelmustbeadequatelytrained,suitable
premisesandequipmentused,correctmaterials
used,approvedproceduresadopted,suitable
storageandtransportfacilitiesavailable,and
appropriaterecordsmade.Theessential
componentsofGMParesummarizedinFigure1.

4. Fig.1. Components of Good Manufacturing Practice

5. Fig. 2. Consolidated Components of Good Manufacturing Practices

6. Theseregulations,whichhavetheforceoflaw,require
thatmanufacturers,processors,andpackagersofdrugs,
medicaldevices,somefood,andbloodtakeproactive
stepstoensurethattheirproductsaresafe,pure,and
effective.GMPregulationsrequireaqualityapproachto
manufacturing,enablingcompaniestominimizeor
eliminateinstancesofcontamination,mixups,and
errors.Thisinturn,protectstheconsumerfrom
purchasingaproductwhichisnoteffectiveoreven
dangerous.FailureoffirmstocomplywithGMP
regulationscanresultinveryseriousconsequences
includingrecall,seizure,fines,andjailtime.
GMPregulationsaddressissuesincludingrecordkeeping,
personnelqualifications,sanitation,cleanliness,equipment
verification,processvalidation,andcomplainthandling.

7. MostGMPrequirementsareverygeneralandopen-
ended,allowingeachmanufacturertodecideindividually
howtobestimplementthenecessarycontrols.
Thisprovidesmuchflexibility,butalsorequiresthatthe
manufacturerinterprettherequirementsinamanner
whichmakessenseforeachindividualbusiness.
GMPisalsosometimesreferredtoas"cGMP".The"c"
standsfor"current,"remindingmanufacturersthatthey
mustemploytechnologiesandsystemswhichareup-to-
dateinordertocomplywiththeregulation.
Systemsandequipmentusedtopreventcontamination,
mixups,anderrors,whichmayhavebeen"top-of-the-line"
20yearsago,maybelessthanadequatebytoday's
standards.

8. IntheDrugsandCosmeticsRules,1945,forScheduleM,the
followingScheduleshallbesubstituted,namely:-
PART–I:GoodManufacturingPracticesforPremisesandMaterials
1.Generalrequirements
A.Locationandsurroundings
B.Buildingsandpremises
C.Watersystem
D.Disposalofwaste
2.WarehousingArea
3.Productionarea
4.Ancillaryareas
5.QualityControlarea
6.Personnel
7.Health,clothingandsanitationofworkers
8.ManufacturingOperationsandControls
9.Sanitationinthemanufacturingpremises
10.Rawmaterials

9. 11.Equipment
12.Documentation and records
13.Labels and other Printed Materials
14.Quality Assurance
15.Self inspection and Quality audit
16.Quality Control System
17.Specification
18.Master Formula Records
19.Packaging Records
20.Batch Packaging Records
21.Batch Processing Records
22.Standard Operating Procedures (SOPs) and Records, regarding
23.Reference samples
24.Reprocessing And Recoveries
25.Distribution records
26.Validation And Process Validation
27.Product recalls
28.Complaints and Adverse Reactions
29.Site Master File

10. PARTI–A:Specificrequirementsformanufactureofsterile
products,parenteralpreparations(smallvolumeinjectablesand
largevolumeparenterals)andsterileophthalmicpreparations.
PARTI–B:Specificrequirementsformanufactureoforalsolid
dosageforms(tabletsandcapsules)
PARTI–C:Specificrequirementsformanufactureoforalliquids
(syrups,elixirs,emulsionsandsuspensions)
PARTI–D:Specificrequirementsformanufactureoftopical
productsi.e.externalpreparations(creams,ointments,pastes,
emulsions,lotions,solutions,dustingpowdersandidentical
products).
PARTI–E:Specificrequirementsformanufactureofmetered–
doseinhalers(MDI)
PARTI–F:Specificrequirementsofpremises,plantandmaterials
formanufactureofactivepharmaceuticalingredients(bulkdrugs).
PARTII:RequirementsofPlantandEquipment.

11. BenefitsofGMPCertification:
•Proveenterprise'smanagementcapabilitiesinproduct
quality,safetyassurance
•Enableemployeestodevelopgoodproduction/
operationshabits
•Reducesafetyriskinproductqualityandsafety
•Timelydetectproductionandmanagementproblems,
reducecost
•Betterunderstandandcomplywiththerelevantlaws
andregulations.
•Enhancetheinternationalcredibilityandpublicimage
•Increasecustomer'slong-termconfidenceinthe
enterprise