good laboratory practice pdf (1).pdf

GLP

1. GOOD LABORATORY PRACTICE

2. In the early 70’s FDA became aware of cases of poorlaboratory
practice all over the UnitedStates.
They discovered a lot fraudulent activities and a lot of poorlab
practices.
Examples of some of these poor lab practices found were:
1.Equipment not been calibrated to standard form , therefore
giving wrongmeasurements.
2.Incorrect/inaccurate accounts of the actual labstudy.
3.Inadequate testsystems.
GLP was first introduced in New Zealand and Denmark in 1972, and later
in the US in 1978 in response to the Industrial Bio Test Labsscandal.

3. Therapeutic
concept
Target
validation
Lead
finding
Target
selection
Lead
optimization
Preclinical
development
Clinical
development
Regulatory
approval
Product
Discovery
Development
Drug Discovery and DevelopmentProcess
Registration
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4. Good Laboratory Practice(GLP)
GLPisaformalregulationcreatedbyUSFDAasthese
regulationswereproposedonNovember19,1976anddesignated
asanewpartofChapter21oftheCodeofFederal
Regulations(CFR)as21CFRPart58in1979.
organizationnamedOECD(OrganizationforIn1981an
EconomicCooperationandDevelopment)producedGLP
principles that are internationalstandards.
GLPinOECDprinciplesisdefinedas“aqualitysystem
concernedwiththeorganizationalprocessandtheconditions
underwhichnon-clinicalhealthandenvironmentalsafetystudies
areplanned,performed,monitored,recorded,archivedand
reported”.
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5. Why GLP wascreated?
1)GLPswereinitiallyinvokedinareactiontomalpracticesinthe
laboratories conducting safety experiments ofmedicines.
2)In the early 1970s,research laboratories in the USA found doing
work in unethical ways,like:
Data generation without conduct of thestudy.
Falsification of the laboratorywork.
Replacement of dead animals and fabrication of test resultsetc.
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6. Advantages ofGLP
Assures that the data are a true reflection of results obtained from
studies.
Preclinical safety and residuesafety.
Generation of high quality and reliable testdata.
Mutual acceptance ofdata
Increases publicconfidence.
Shortens the time-to-market for newproducts.
Disadvantages ofGLP
More man power is required.
Expensiveprocess.
Time consumingprocess.
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7. Objectives of
GLP
1)GLP makes sure that the data submitted are true reflection ofthe
results obtained from thestudies.
2)GLP makes sure that the data istraceable.
3)Promotes international acceptance oftests.
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8. GLP
Principles
Testing
facility
organization
and
personnel
Storage
and
retention
ofrecords
and
materials
Reporting
of study
results
Quality
assurance
program
Facilities
Apparatus,
materials
,reagents
Test
systems
Test and
reference
substances
Standard
operating
procedures
Performance
ofstudy
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9. How to practiceGLP?
A.Generalprovisions
B.Organization andPersonnel
C.Facilities
D.Equipment
E.Testing facilitiesoperation
F.Test and controlarticles
G.Protocol for and the conduct of thestudy
H.Records andReports
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10. A. General
provisions
1)It prescribes GLP for conducting non-clinical laboratorystudies
thatsupportresearchandmarketingpermitsofproducts
regulated byFDA.
2)Applicability to studies performed under grants andcontracts.
3)Inspection of the testingfacility.
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11. B. Organization and
Personnel
1)Organization
2)Personnel
3)Testing facilitymanagement
4)Studydirector
5)Quality assuranceunit
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12. Organization-
Functions
1)Identification of qualityactivities.
2)Dividing the jobs among thepersonnel.
ofeachjoband3)Definetheauthorityandresponsibility
relationship of each job with otherjobs.
4)Coordinate the work of internal departments and outsideagencie
1
s
0
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13. Personne
l
Eachindividualengagedintheconductorsupervisionofnon-
clinical laboratory study shallhave:
1)Education
2)Training:
a)Generaltraining
b)Specifictraining
3)Experience orcombination
4)Personal sanitation and healthprecautions
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14. Testing facility
management
1)A sufficient number of qualified personnel, appropriatefacilities,
equipmentandmaterialsareavailableforconductanceofthe
study.
2)Maintenance of records of qualifications, training and experience
of personnel and their jobdescription.
3)Appointment of studydirector.
4)Quality assurance program with designatedpersonnel.
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15. Study
DirectorA scientist or other professional of appropriate education , training
andexperience.
Responsibilities of the study directorare:
1)Approval of protocol and study plans includingamendments.
2)Technical conduct of thestudy.
3)Ensure that the QA personnel and study personnel are updated
with the study plan andSOPs.
4)Interpretation,analysis,documentationandreportingofthe
results.
5)Alsochecksthatexperimentaldataisaccuratelyrecordedand
verified.
6)Sign and date the final report for acceptance ofdata.
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16. Quality AssuranceUnit
1)Anindividualoragroupdesignatedbymanagementtoassure
thatthestudiesareincompliancewithGLPprinciples.
2)Monitorsthestudytoassuremanagementthatthefacilities,
equipment,personnel,methods,practices,recordsandcontrols
areinconformancewiththeregulations.
3)Maintainthecopiesofmasterschedulesheet,protocoland
SOPs.
4)Access to updated study plans andSOPs.
5)Documented verification of compliance of the studywith GLP
principles.
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17. Cont.…
5)Inspections to determine the compliance of the study with GLP
principles and three type of inspectionsare:
a)Study basedinspections
b)Process basedinspections
c)Facility basedinspections
6)Determines any deviation from the approved protocol and report
to SD,PI andmanagement.
7)Preparestatementstobeincludedinthefinalreportcontaining
dates and types ofinspection. 17

18. C.
Facilities
1)Generalfacilities:
a)Testing systemfacilities
b)Archive facilities
c)Wastedisposal
2)Animal carefacilities
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19. General
facilities
a)Testing systemfacilities
Suitable size, construction andlocation.
Adequate degree of separation of differentactivities.
Laboratoriesshouldbewellventilated,freeofdust,draftsand
extremetemperatures.
Minimum 150sq.feet of floor space and minimum 6 linear feet of
usable bench space should be provide for eachanalyst.
b)Archivefacilities-Securestorageandretrievalofstudyplans,
rawdata,finalreportandspecimenstopreventuntimely
deterioration.
c)Wastedisposal-Appropriatecollection,storageanddisposal
facilities and decontaminationprocedures.
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20. Animal care
facilities
1)Located away form testing laboratories preferably in a separatebuilding.
2)Contaminationriskisreducedby“barrier”system,aswellasbyproviding
“clean” and “dirty” corridors.
3)Separate areas for animals of different species andstudies.
4)Separateareasfordiagnosis,treatmentandcontroloflaboratoryanimal
diseases.
5)Lightening should be proper as light intensity and noise level issufficient.
6)Maintain room temperature, humidity and air changes in animalquarters.
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21. D.Equipment
cleanedand
1)Appropriate design and adequatecapacity.
2)Equipmentshallbeadequatelyinspected,
maintained.
3)Equipment used for generation, measurement or assessment of
data shall be adequately tested, calibrated andstandardized.
4)Log books for each equipment should bethere.
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22. E. Testing Facilities
Operation
1)Standard operating procedures(SOPs)
2)Reagents andsolutions
3)Animalcare
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23. Standard Operating Procedures
(SOPs)
referenceitems,apparatus,materialsandreagents,recordkeeping,
reporting,storageandretrieval,testsystemsandqualityassurance
procedures.
4) Any deviation from SOPshould beauthorized
by SD and documented in the rawdata.
1)Writtendocumentsspecifyingproceduresforlaboratories
programs.
2)TestingfacilityshouldhaveawrittenSOPapprovedby
management.
3)SOPsshouldbeavailablewhereverapplicablee.g.testand
testingand5)Routineinspection,cleaning,maintenance,
calibration.
6)Actions to be taken in response to routinefailure.
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24. Reagents and
solutions
1)Reagents used in the operation should be specified in theSOPs.
2)Reagents and solutions should belabeled.
3)Deteriorated or outdated reagents and solutions should not beused.
4)Store under ambienttemperature.
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25. Animal
care1)SOPs -for housing, feeding, handling and care ofanimals.
2)Animalsshouldbefreeofanydiseaseandif,duringthecourse
ofstudy,animalscontractadiseasethenthediseasedanimals
shallbeisolated.
3)Diagnosis,authorizationoftreatment,descriptionanddateof
treatment shall be documented andretained.
4)Animalsofdifferentspeciesshallbehousedinseparatedrooms
whennecessary.
5)Theanimalcages,racksandaccessoryequipmentshallbe
cleaned and sanitized at appropriateintervals.
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26. F. Test and ControlArticles
1)Test and control articlecharacterization
2)Test and control articlehandling
3)Mixture of articles withcarriers
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27. Test and control article
characterization1)Theidentity,strength,purityandcompositionorother
characteristicsoftestandcontrolarticleshallbedeterminedand
documentedforeachbatch.
2)Methodsofsynthesis,fabricationorderivationshallbe
documented by the sponsor or the testingfacility.
3)Stability of each test and control article isdetermined.
4)Storageconditionsaremaintainedandeachstoragecontainer
shallbelabeledbyname,chemicalabstractnumberorbatch
number.
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28. Test and control article
handlingHandling procedures of test and control articlesensures:
1)Properstorage.
2)Minimum risk of contamination and deterioration ordamage.
batch
3)Receipt and distribution of each batch isdocumented.
4)Documentationincludedateandquantityofeach
distributed orreturned.
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29. Mixture of articles with
carriers
1)Appropriateanalyticalmethodsshallbeconductedfor
determination of uniformity of mixture and concentration of test
or control article inmixture.
2)Stability of mixture isdetermined.
3)Expiration date should be written on thecontainer.
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30. G. Protocol for and conduct of
a nonclinical laboratorystudy
1)Protocol
2)Conduct of a nonclinicalstudy
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31. Protoco
lContents ofprotocol
1.Identification
2.Title and statement ofpurpose
3.Identification of test(or control)items
4.Names and address of the sponsor, test facility and testsite
5.Name of the study director and otherpersonnel
6.Proposeddates
7.Justification for selection of the testsystem
8.Description of the testsystem
9. Experimentaldesign
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32. Conduct of a nonclinical laboratory
study
1)Study shall be conducted in accordance with theprotocol.
2)Information of the specimens should be present on the container
to avoid error in recording and storage ofdata.
3)All the data generated shall be recorded directly, promptly and
legibly byink.
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33. H. Records and
Reports
1)Reporting of nonclinical laboratoryresults
2)Storage, retrieval and retention of records anddata
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34. Reporting of nonclinical laboratory study
results
Final report shallcontain:
1)Information on sponsor and testfacility.
2)Experimental starting and completiondates.
3)Objectives and procedures stated in protocol(including the changes
inprotocol).
4)Description of materials and testmethods.
5)A Quality Assurance Programstatement.
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6)Storage(specimens, reference items, raw data and finalreport).

35. Storage, retrieval and retention of
records and data1)Archives should be there for orderly storage and expedient of all
raw data, documentation, protocols, specimens and finalreports.
2)Index of materialsretained.
3)Masterschedulesheet,copiesofprotocolsandrecordsof
Quality Assurance inspections shallbemaintainedbyQAU.
4)Wet specimens and samples of test and control articles shall be
retained until the quality of preparation affordsevaluation.
5)Ifanystudyplanisdisposedofbeforeexpirythereasontobe
justified anddocumented. 35

36. Conclusion
GLPisaFDAregulationwhichisacceptedandapprovedas
internationalstandardsbyOECDtoavoidfraudactivitiesofthe
testinglaboratoriesforpharmaceuticalstosavehumanand
environmentalhealth.
GivesbetterimageofcompanyasaQualityproduceringlobal
market.
Also it establish good relationship among thecountries.
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