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GLPGLPA General Understanding and OverviewA General Understanding and Overview

January 5, 2005

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To proceed directly to the GLP test, please follow the link below.

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GLPGLP

Good Laboratory PracticesGood Laboratory Practices

Defined by the Code of Federal Regulations (21CFR Part 58)Defined by the Code of Federal Regulations (21CFR Part 58)

Section 21 of the CFR is specific to the FDASection 21 of the CFR is specific to the FDA

Enforced by the Food and Drug Administration (FDA)Enforced by the Food and Drug Administration (FDA)

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Intent ofthe GLPsIntent ofthe GLPs

To assureTo assure qualityandintegrityqualityandintegrity of dataof data

submitted to the FDAsubmitted to the FDA

To allow forTo allow for accuratereconstructionaccuratereconstruction of aof astudystudy

To assist with the approval and manufacture ofTo assist with the approval and manufacture of

products that areproducts that are safe forconsumerssafe forconsumers

Copyright 2004 Robin Guy

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FDAGLPsFDAGLPs

Good Laboratory Practices as definedbytheGood Laboratory Practices as definedbythe

FDAFDAshould not be confused with goodshould not be confused with good

labo

rato

ry prac

tic

esc

urrently being do

ne in yo

urlabo

rato

ry prac

tic

esc

urrently being do

ne in yo

urlablab

GLPGLP == good lab practicesgood lab practices

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GLPsGLPs

DoDo notnot assureassure GoodGood ScienceScience

DoDo notnot informinform scientistsscientists whatwhat teststests toto performperform DoDo notnot informinform scientistsscientists whatwhat thethe scientificscientific contentscontents

ofof thethe studystudy protocolprotocol shouldshould bebe


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Effect of GLP NoncomplianceEffect of GLP Noncompliance

If a safety study wasIf a safety study was notnot conducted according toconducted according to

GLPs, and submitted to the FDA, the FDA willGLPs, and submitted to the FDA, the FDA will

refuse toconsider its submissionrefuse toconsider its submission

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FDAOverviewFDAOverview

The FDA is a federal agency thatThe FDA is a federal agency that

Approves the safety and effectiveness of drugs andApproves the safety and effectiveness of drugs andmedical/biological/electronic devicesmedical/biological/electronic devices

Maintains the nutritional standard and safetyof foodsMaintains the nutritional standard and safetyof foods

Ensures the safetyofcosmetics and consumer productsEnsures the safetyofcosmetics and consumer products

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FDAOverviewFDAOverview

The FDA is also a law enforcementThe FDA is also a law enforcementagency and routinely refers to theagency and routinely refers to the

Department of Justice recommendationsDepartment of Justice recommendationsfor investigation or prosecutionfor investigation or prosecution

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InvestigationInvestigationFDAs FocusFDAs Focus

Deliberate orDeliberate or repeatedrepeated noncompliance with thenoncompliance with theregulations or falsification of data are consideredregulations or falsification of data are consideredto be misconduct by the FDAto be misconduct by the FDA CASE was inspected in 1994 and 2003CASE was inspected in 1994 and 2003

SanctionsSanctions (OAI) Official Action Indicated(OAI) Official Action Indicated

Regulatory and administrative actions will beRegulatory and administrative actions will berecommendedrecommended

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ProsecutionProsecution

Individuals as well as the Institution can beIndividuals as well as the Institution can becriminally prosecuted under Title 18 of thecriminally prosecuted under Title 18 of the

U.S. Criminal CodeU.S. Criminal Code

ImprisonmentImprisonment

FinesFines

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Outline ofthe GLPsOutline ofthe GLPs

1111 SubpartsSubparts ((22 reserved)reserved):: A=A= GeneralGeneral ProvisionsProvisions

B=B= OrganizationOrganization && PersonnelPersonnel

C=C= FacilitiesFacilities

D=D= EquipmentEquipment

E= TestingFacilities OperationsE= TestingFacilities Operations

F= TestandControlArticlesF= TestandControlArticles

G= Protocol forandConduct ofa NonG= Protocol forandConduct ofa Non--clinicalclinical

Laboratory StudyLaboratory Study

HH && I=I= [Reserved][Reserved]

J=J= RecordsRecords andand ReportsReports

K=K= DisqualificationDisqualification

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SubpartASubpartA General ProvisionsGeneral Provisions

58.1 Scope58.1 Scope

The GLPs prescribegoodlaboratoryThe GLPs prescribegoodlaboratory

practices forconductingpractices forconductingnonclinicalnonclinicallaboratory studieslaboratory studies thatthatsupportapplicationssupportapplications

forresearch ormarketingpermits forforresearch ormarketingpermits for

products regulatedbytheFDA.products regulatedbytheFDA.


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GLP applies to safetytesting for:GLP applies to safetytesting for:

FoodandcoloradditivesFoodandcoloradditives AnimaladditivesAnimaladditives

HumanandanimaldrugsHumanandanimaldrugs

MedicaldevicesMedicaldevices Biological&electronicproductsBiological&electronicproducts

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GLPs do notcover:GLPs do notcover:

Human subjectsHuman subjects

Field studies inanimalsField studies inanimals

Basicexploratory studies to determine:Basicexploratory studies to determine:

PotentialutilityPotentialutility Physical orchemicalcharacteristics ofatestarticlePhysical orchemicalcharacteristics ofatestarticle

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CASE Warning LetterCASE Warning Letter

As a result of an FDA inspection which wasAs a result of an FDA inspection which was

conducted from October 23 throughconducted from October 23 through

December 9 2003December 9 2003

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FDAFindingsFDAFindings

Failure to provide adequate testing facility managementFailure to provide adequate testing facility management[21 CFR 58.31 (a), (c), (f)][21 CFR 58.31 (a), (c), (f)]

Failure to provide adequate study direction [21 CFRFailure to provide adequate study direction [21 CFR58.33]58.33]

Failure to have a Quality Assurance Unit [21 CFRFailure to have a Quality Assurance Unit [21 CFR58.35]58.35]

Failure to maintain records for the maintenance andFailure to maintain records for the maintenance andcalibration of equipment [21 CFR 58.63 (a)]calibration of equipment [21 CFR 58.63 (a)]

Failure to maintain study documentation and to storeFailure to maintain study documentation and to storematerials in an orderly manner for expedient retrievalmaterials in an orderly manner for expedient retrieval[21 CFR 58.190][21 CFR 58.190]

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GLP TerminologyGLP Terminology

Need to recognize terminology unique to GLPsNeed to recognize terminology unique to GLPs Test Article (TA)Test Article (TA)

Control ArticleControl Article

Test SystemTest System

Testing FacilityTesting Facility

Testing Facility ManagementTesting Facility Management

Quality Assurance Unit (QAU)Quality Assurance Unit (QAU) Raises red flags and questions!Raises red flags and questions!

Avoid the use of this terminologyAvoid the use of this terminology

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CompareandContrastCompareandContrast

WhyCASEis not GLP!WhyCASEis not GLP!

FDAGLP REQUIRESFDAGLP REQUIRES

Testing Facility ManagementTesting Facility Management

Study DirectorStudy Director

Quality Assurance UnitQuality Assurance Unit

Equipment requires scheduledEquipment requires scheduled

maintenance and SOPsmaintenance and SOPs

Archived, orderly storage forArchived, orderly storage forall records, documentation andall records, documentation andfeasible specimens forfeasible specimens for

expedient retrievalexpedient retrieval

CASEIS NOT GLPCASEIS NOT GLP

CASE does not have aCASE does not have a TestingTestingFacility ManagementFacility Management

Must be appo

inted by theMust be appo

inted by theTesting Facility ManagementTesting Facility Management

CASE does not have a QualityCASE does not have a QualityAssurance UnitAssurance Unit

Equipment may requireEquipment may require

scheduled maintenance, SOPsscheduled maintenance, SOPsare not required at CASEare not required at CASE

Storage requirements are notStorage requirements are notdetailed at CASEdetailed at CASE

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TestingFacilityRequirementsTestingFacilityRequirements

GLP studies follow a chain ofcustodyGLP studies follow a chain ofcustody Testing Facility ManagementTesting Facility Management

Study DirectorStudy Director

Quality Assurance UnitQuality Assurance Unit

Extensive detailed recordExtensive detailed record--keeping requirementskeeping requirements Legal Documents (must support a federal investigation)Legal Documents (must support a federal investigation)

SOPs (special format)SOPs (special format)

Archived storage of recordsArchived storage of records

GLP studies generally separate from nonGLP studies generally separate from non--GLPGLP GLP studies isolated from each otherGLP studies isolated from each other

The Animal Facilities at CASE are not GLP!The Animal Facilities at CASE are not GLP!

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CASEis not GLPCASEis not GLP

CASE does not use GLP principles in its operationCASE does not use GLP principles in its operation

CASE does not choose who will be on a protocolCASE does not choose who will be on a protocol

CASE does not have a Quality Assurance UnitCASE does not have a Quality Assurance Unit

CASE Animal Facilities were not constructed to support GLPCASE Animal Facilities were not constructed to support GLPstudiesstudies

CASE Animal Facilities are not operating under the restrictiveCASE Animal Facilities are not operating under the restrictive

principles of GLPprinciples of GLP

ThereforeTherefore

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GLP studiesGLP studies cannotcannot

beconductedatbeconductedatCASECASE

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FDASubmissionFDASubmission

AllAll GLP principles must be followed whenGLP principles must be followed when

FDA submission is your goalFDA submission is your goal

CASE is no

t a GLP Facility and

cann

ot supp

ortCASE is n

ot a GLP Fa

cility and

cann

ot supp

ortyour safety testing for FDA submissionyour safety testing for FDA submission

You will need to find an outside source toYou will need to find an outside source to

conduct your final GLP safety studiesconduct your final GLP safety studies

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FDASubmissionFDASubmission

CASE is exploring possible options for contractingCASE is exploring possible options for contractingwith outside testing facilities for GLP studieswith outside testing facilities for GLP studies

Until we have such mechanisms in place, if you haveUntil we have such mechanisms in place, if you havequestions or concerns regarding GLP studies or FDAquestions or concerns regarding GLP studies or FDAsubmission, please contactsubmission, please contact

Anne DuliAnne DuliAssistant Dean for Research AdministrationAssistant Dean for Research Administration

School of MedicineSchool of [email protected]@case.eduPhone 368Phone 368--44324432

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TestTest

Thank you for completing this training module.Thank you for completing this training module.

In order tocomplete the module and documentIn order tocomplete the module and document

yo

ur partcipati

on please answer the f

oll

owingy

our part

cipati

on please answer the f

oll

owingquestions and submit the appropriatequestions and submit the appropriate

information.information.

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