1 - Aceitacao de Dados Na Avaliacao de Quimicos

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Decisions,RecommendationsandotherInstruments
DECISION
CHEMICALS
DecisionoftheCouncilconcerningtheMutualAcceptanceofDatainthe
AssessmentofChemicals
12May1981C(81)30/FINAL
TechnicalAmendment
26May1983C(83)44
Addendum2toC(81)30(Final)
4April1984C(84)32
7June1984ENV(84)10
23October1986C(86)143
24February1987C(86)191
30March1989C(89)23(Final)
17July1992C(92)102/FINAL
22March1996C(96)14/FINAL
17June1996C(96)58/FINAL
16October1997C(2007)107
Amendedon
26November1997C(97)186/FINAL
TechnicalAmendment
21September1998C(98)142/FINAL
21January2000C(99)189/FINAL
22January2000C(2000)228
17December2001C(2001)282
24April2002C(2002)76
13April2004C(2004)28
23March2006C(2006)13
19June2006C(2006)101
8January2007C(2006)169
3October2008C(2008)143
7September2009C(2009)103
22July2010C(2010)97
28July2011C(2011)101
2October2012C(2012)111
26July2013C(2013)78
26September2014C(2014)104
THECOUNCIL,
HAVINGREGARDtoArticles2a),2d),3,5a)and5b)oftheConventionontheOrganisationforEconomicCooperationand
Developmentof14December1960
HAVING REGARD to the Recommendation of the Council of 26 May 1972, on Guiding Principles concerning International
EconomicAspectsofEnvironmentalPolicies[C(72)128]
HAVING REGARD to the Recommendation of the Council of 14 November 1974, on the Assessment of the Potential
EnvironmentalEffectsofChemicals[C(74)215]
HAVINGREGARDtotheRecommendationoftheCouncilof26August1976,concerningSafetyControlsoverCosmeticsand
HouseholdProducts[C(76)144(Final)]
HAVINGREGARDtotheRecommendationoftheCouncilof7July1977,establishingGuidelinesinrespectofProcedureand
RequirementsforAnticipatingtheEffectsofChemicalsonManandintheEnvironment[C(77)97(Final)]
HAVINGREGARDtotheDecisionoftheCouncilof21September1978,concerningaSpecialProgrammeontheControlof
ChemicalsandtheProgrammeofWorkestablishedtherein[C(78)127(Final)]
HAVINGREGARDtotheConclusionsoftheFirstHighLevelMeetingoftheChemicalsGroupof19 May 1980, dealing with
thecontrolofhealthandenvironmentaleffectsofchemicals[ENV/CHEM/HLM/80.M/1]
CONSIDERING the need for concerted action amongst OECD Member countries to protect man and his environment from
exposuretohazardouschemicals
CONSIDERING the importance of international production and trade in chemicals and the mutual economic and trade
advantageswhichaccruetoOECDMembercountriesfromharmonizationofpoliciesforchemicalscontrol
http://webnet.oecd.org/OECDACTS/Instruments/PrintInstrumentView.aspx?InstrumentID=263&ampInstrumentPID=339&InstrumentHID=0&ampLang=en
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CONSIDERINGtheneedtominimisethecostburdenassociatedwithtestingchemicalsandtheneedtoutilisemoreeffectively
scarcetestfacilitiesandspecialistmanpowerinMembercountries
CONSIDERINGtheneedtoencouragethegenerationofvalidandhighqualitytestdataandnotingthesignificantactionstaken
in this regard by OECD Member countries through provisional application of OECD Test Guidelines and OECD Principles of
GoodLaboratoryPractice
CONSIDERINGthe need for and benefits of mutual acceptance in OECD countries of test data used in the assessment of
chemicalsandotherusesrelatingtoprotectionofmanandtheenvironment
OntheproposaloftheHighLevelMeetingoftheChemicalsGroup,endorsedbytheEnvironmentCommittee
PARTI
I. DECIDES that data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test
Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of
assessmentandotherusesrelatingtotheprotectionofmanandtheenvironment.
II.DECIDES that for the purposes of this Decision and other Council actions the terms OECD Test Guidelines and OECD
PrinciplesofGoodLaboratoryPracticeshallmeanguidelinesandprinciplesadoptedbytheCouncil.
III.INSTRUCTStheEnvironmentCommitteetoreviewactiontakenbyMembercountriesinpursuanceofthisDecisionandto
reportperiodicallythereontotheCouncil.
IV. INSTRUCTS the Environment Committee to pursue a programme of work designed to facilitate implementation of this
DecisionwithaviewtoestablishingfurtheragreementonassessmentandcontrolofchemicalswithinMembercountries.
PARTII
ToimplementtheDecisionsetforthinPartI:
I. RECOMMENDS that Member countries, in the testing of chemicals, apply the OECD Test Guidelines and the OECD
PrinciplesofGoodLaboratoryPractice,setforthrespectivelyinAnnexesIandIIwhichareintegralpartsofthistext.
II.INSTRUCTStheManagementCommitteeoftheSpecialProgrammeontheControlofChemicalsinconjunctionwiththe
Chemicals Group of the Environment Committee to establish an updating mechanism to ensure that the aforementioned Test
Guidelines are modified from time to time, as required, through the revision of existing Guidelines or the development of new
Guidelines.
III.INSTRUCTStheManagementCommitteeoftheSpecialProgrammeontheControlofChemicalstopursueitsprogramme
of work in such a manner as to facilitate internationallyharmonized approaches to assuring compliance with the OECD
PrinciplesofGoodLaboratoryPracticeandtoreportperiodicallythereontotheCouncil.
ANNEXI
OECDTESTGUIDELINES
These Guidelines have been published under the reference C(81)30, Annex I and Addenda. This document, which is updated
periodically,
can
be
purchased
from
the
OECD
Publications
Service
and
is
online
at:
http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm.
_________________________________
LISTOFAMENDMENTSTOTHEDECISIONOFTHECOUNCILC(81)30/FINALCONCERNINGTESTGUIDELINES
26May1983Addendum2toC(81)30(Final)(6newGuidelines)
4April1984Addendum3toC(81)30(Final)(13newGuidelinesand2updated)
7June1984Addendum4toC(81)30(Final)(1updatedGuideline)
23October1986Addendum5toC(81)30(Final)(7newGuidelines)
24February1987Addendum6toC(81)30(Final)(3updatedGuidelines)
30March1989C(89)23(Final)(1newGuideline)
17July1992C(92)102/FINAL(3newGuidelinesand5updated)
27July1995C(95)106/FINAL(1newGuidelineand10updated)
22March1996C(96)14/FINAL(2newGuidelines)
17June1996C(96)58/FINAL(3newGuidelinesand1updated)
21July1997C(97)94/FINAL(2newGuidelinesand6updated)
21September1998C(98)142/FINAL(4newGuidelinesand3updated)
21January2000C(99)189/FINAL(3newGuidelinesand2updated)
22January2001C(2000)228(1newGuidelineand3updated)
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17December2001C(2001)282(3updatedGuidelinesand1deleted)
24April2002C(2002)76(3newGuidelinesand2updated)
13April2004C(2004)28(11newGuidelinesand3updated)
23March2006C(2006)13(4newGuidelinesand3updated)
19July2006C(2006)101(2newGuidelinesand1updated)
8January2007C(2006)169(6newGuidelinesandnewSection5:OtherTestGuidelinesPartA:PesticideResidue
Chemistry)
16October2007C(2007)107(6newGuidelines)
3October2008C(2008)143(6newGuidelines,2updatedand1corrected)
7September2009C(2009)103(10newGuidelines,6updatedand1corrected)
22July2010C(2010)97(7newGuidelines,3updatedand1corrected)
28July2011C(2011)101(5newGuidelinesand1corrected)
2October2012C(2012)111(2newGuidelines,7updated,1correctedand7deleted)
26July2013C(2013)78(3newGuidelines,8updatedand1corrected)
26September2014C(2014)104(3newGuidelines,5updatedand1corrected)
ANNEXII
OECDPRINCIPLESOFGOODLABORATORYPRACTICE
(asrevisedin1997)
SECTIONI:INTRODUCTION
Preface
Government and industry are concerned about the quality of nonclinical health and environmental safety studies upon which
hazardassessmentsarebased.Asaconsequence,OECDMembercountrieshaveestablishedcriteriafortheperformanceof
thesestudies.
Toavoiddifferentschemesofimplementationthatcouldimpedeinternationaltradeinchemicals,OECDMembercountrieshave
pursuedinternationalharmonisation of test methods and good laboratory practice. In 1979 and 1980, an international group of
experts established under the Special Programme on the Control of Chemicals developed the OECD Principles of Good
Laboratory Practice (GLP), utilising common managerial and scientific practices and experience from various national and
international sources. These Principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council
DecisionontheMutualAcceptanceofDataintheAssessmentofChemicals[C(81)30(Final)].
In1995and1996,anewgroupofexpertswasformedtoreviseandupdatethePrinciples.Thecurrentdocumentistheresultof
theconsensusreachedbythatgroup.ItcancelsandreplacestheoriginalPrinciplesadoptedin1981.
The purpose of these Principles of Good Laboratory Practice is to promote the development of quality test data. Comparable
quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently
rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The
applicationofthesePrinciplesshouldhelptoavoidthecreationoftechnicalbarrierstotrade,andfurtherimprovetheprotection
ofhumanhealthandtheenvironment.
1.Scope
These Principles of Good Laboratory Practice should be applied to the nonclinical safety testing of test items contained in
pharmaceuticalproducts,pesticideproducts,cosmeticproducts,veterinarydrugsaswellasfoodadditives,feedadditives,and
industrialchemicals.Thesetestitemsarefrequentlysyntheticchemicals,butmaybeofnaturalorbiologicaloriginand,insome
circumstances,maybelivingorganisms.Thepurposeoftestingthesetestitemsistoobtaindataontheirpropertiesand/ortheir
safetywithrespecttohumanhealthand/ortheenvironment.
Nonclinical health and environmental safety studies covered by the Principles of Good Laboratory Practice include work
conductedinthelaboratory,ingreenhouses,andinthefield.
Unlessspecificallyexemptedbynationallegislation,thesePrinciplesofGoodLaboratoryPracticeapplytoallnonclinicalhealth
andenvironmentalsafetystudiesrequiredbyregulationsforthepurposeofregisteringorlicensingpharmaceuticals,pesticides,
food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial
chemicals.
2.DefinitionsofTerms
2.1GoodLaboratoryPractice
1. Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under
whichnonclinicalhealthandenvironmentalsafetystudiesareplanned,performed,monitored,recorded,archivedandreported.
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2.2TermsconcerningtheOrganisationofaTestFacility
1.Testfacilitymeansthepersons,premisesandoperationalunit(s)thatarenecessaryforconductingthenonclinicalhealth
and environmental safety study. For multisite studies, those which are conducted at more than one site, the test facility
comprisesthesiteatwhichtheStudyDirectorislocatedandallindividualtestsites,whichindividuallyorcollectivelycanbe
consideredtobetestfacilities.
2.Testsitemeansthelocation(s)atwhichaphase(s)ofastudyisconducted.
3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and
functioningofthetestfacilityaccordingtothesePrinciplesofGoodLaboratoryPractice.
4.Testsitemanagement(ifappointed)meanstheperson(s)responsibleforensuringthatthephase(s)ofthestudy,forwhich
heisresponsible,areconductedaccordingtothesePrinciplesofGoodLaboratoryPractice.
5.Sponsormeansanentitywhichcommissions,supportsand/orsubmitsanonclinicalhealthandenvironmentalsafetystudy.
6.StudyDirectormeanstheindividualresponsiblefortheoverallconductofthenonclinicalhealthandenvironmentalsafety
study.
7.PrincipalInvestigatormeansanindividualwho,foramultisitestudy,actsonbehalfoftheStudyDirectorandhasdefined
responsibilityfordelegatedphasesofthestudy.TheStudyDirector'sresponsibilityfortheoverallconductofthestudycannot
bedelegatedtothePrincipalInvestigator(s)thisincludesapprovalofthestudyplananditsamendments,approvalofthefinal
report,andensuringthatallapplicablePrinciplesofGoodLaboratoryPracticearefollowed.
8.QualityAssuranceProgrammemeansadefinedsystem,includingpersonnel,whichisindependentofstudyconductandis
designedtoassuretestfacilitymanagementofcompliancewiththesePrinciplesofGoodLaboratoryPractice.
9.StandardOperatingProcedures (SOPs) means documented procedures which describe how to perform tests or activities
normallynotspecifiedindetailinstudyplansortestguidelines.
10. Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of
studiesatatestfacility.
2.3TermsconcerningtheNonclinicalHealthandEnvironmentalSafetyStudy
1.Nonclinicalhealthandenvironmentalsafetystudy,henceforthreferredtosimplyas"study",meansanexperimentorsetof
experimentsinwhichatestitemisexaminedunderlaboratoryconditionsorintheenvironmenttoobtaindataonitsproperties
and/oritssafety,intendedforsubmissiontoappropriateregulatoryauthorities.
2.Shorttermstudymeansastudyofshortdurationwithwidelyused,routinetechniques.
3. Studyplan means a document which defines the objectives and experimental design for the conduct of the study, and
includesanyamendments.
4.Studyplanamendmentmeansanintendedchangetothestudyplanafterthestudyinitiationdate.
5.Studyplandeviationmeansanunintendeddeparturefromthestudyplanafterthestudyinitiationdate.
6.Testsystemmeansanybiological,chemicalorphysicalsystemoracombinationthereofusedinastudy.
7.Rawdatameansalloriginaltestfacilityrecordsanddocumentation,orverifiedcopiesthereof,whicharetheresultofthe
original observations and activities in a study. Raw data also may include, for example, photographs, microfilm or microfiche
copies,computerreadablemedia,dictatedobservations,recordeddatafromautomatedinstruments,oranyotherdatastorage
mediumthathasbeenrecognisedascapableofprovidingsecurestorageofinformationforatimeperiodasstatedinsection10
below.
8.Specimenmeansanymaterialderivedfromatestsystemforexamination,analysis,orretention.
9.Experimentalstartingdatemeansthedateonwhichthefirststudyspecificdataarecollected.
10.Experimentalcompletiondatemeansthelastdateonwhichdataarecollectedfromthestudy.
11.StudyinitiationdatemeansthedatetheStudyDirectorsignsthestudyplan.
12.StudycompletiondatemeansthedatetheStudyDirectorsignsthefinalreport.
2.4TermsconcerningtheTestItem
1.Testitemmeansanarticlethatisthesubjectofastudy.
2.Referenceitem("controlitem")meansanyarticleusedtoprovideabasisforcomparisonwiththetestitem.
3.Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in
suchawaythatitcouldbeexpectedtobeofauniformcharacterandshouldbedesignatedassuch.
4.Vehiclemeansanyagentwhichservesasacarrierusedtomix,disperse,orsolubilise the test item or reference item to
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facilitatetheadministration/applicationtothetestsystem.
SECTIONII:GOODLABORATORYPRACTICEPRINCIPLES
1.TestFacilityOrganisationandPersonnel
1.1TestFacilityManagement'sResponsibilities
1.EachtestfacilitymanagementshouldensurethatthesePrinciplesofGoodLaboratoryPracticearecompliedwith,initstest
facility.
2.Ataminimumitshould:
a)Ensurethatastatementexistswhichidentifiestheindividual(s)withinatestfacilitywhofulfilltheresponsibilitiesof
managementasdefinedbythesePrinciplesofGoodLaboratoryPractice
b)Ensurethatasufficientnumberofqualifiedpersonnel,appropriatefacilities,equipment,andmaterialsareavailable
forthetimelyandproperconductofthestudy
c) Ensure the maintenance of a record of the qualifications, training, experience and job description for each
professionalandtechnicalindividual
d)Ensurethatpersonnelclearlyunderstandthefunctionstheyaretoperformand,wherenecessary,providetraining
forthesefunctions
e) Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and
approvealloriginalandrevisedStandardOperatingProcedures
f) Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality
assuranceresponsibilityisbeingperformedinaccordancewiththesePrinciplesofGoodLaboratoryPractice
g)Ensurethatforeachstudyanindividualwiththeappropriatequalifications,training,andexperienceisdesignatedby
the management as the Study Director before the study is initiated. Replacement of a Study Director should be done
accordingtoestablishedprocedures,andshouldbedocumented
h)Ensure,intheeventofamultisitestudy,that,ifneeded,aPrincipalInvestigatorisdesignated,whoisappropriately
trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal
Investigatorshouldbedoneaccordingtoestablishedprocedures,andshouldbedocumented
i)EnsuredocumentedapprovalofthestudyplanbytheStudyDirector
j)EnsurethattheStudyDirectorhasmadetheapprovedstudyplanavailabletotheQualityAssurancepersonnel
k)EnsurethemaintenanceofanhistoricalfileofallStandardOperatingProcedures
l)Ensurethatanindividualisidentifiedasresponsibleforthemanagementofthearchive(s)
m)Ensurethemaintenanceofamasterschedule
n)Ensurethattestfacilitysuppliesmeetrequirementsappropriatetotheiruseinastudy
o) Ensure for a multisite study that clear lines of communication exist between the Study Director, Principal
Investigator(s),theQualityAssuranceProgramme(s)andstudypersonnel
p)Ensurethattestandreferenceitemsareappropriatelycharacterised
q) Establish procedures to ensure that computerised systems are suitable for their intended purpose, and are
validated,operatedandmaintainedinaccordancewiththesePrinciplesofGoodLaboratoryPractice.
3.Whenaphase(s)ofastudyisconductedatatestsite,testsitemanagement(ifappointed)willhavetheresponsibilitiesas
definedabovewiththefollowingexceptions:1.1.2g),i),j)ando).
1.2StudyDirector'sResponsibilities
1.TheStudyDirectoristhesinglepointofstudycontrolandhastheresponsibilityfortheoverallconductofthestudyandfor
itsfinalreport.
2.Theseresponsibilitiesshouldinclude,butnotbelimitedto,thefollowingfunctions.TheStudyDirectorshould:
a)Approvethestudyplanandanyamendmentstothestudyplanbydatedsignature
b) Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely
mannerandcommunicateeffectivelywiththeQualityAssurancepersonnelasrequiredduringtheconductofthestudy
c)EnsurethatstudyplansandamendmentsandStandardOperatingProceduresareavailabletostudypersonnel
d) Ensure that the study plan and the final report for a multisite study identify and define the role of any Principal
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Investigator(s)andanytestfacilitiesandtestsitesinvolvedintheconductofthestudy
e)Ensurethattheproceduresspecifiedinthestudyplanarefollowed,andassessanddocumenttheimpactofany
deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if
necessaryacknowledgedeviationsfromStandardOperatingProceduresduringtheconductofthestudy
f)Ensurethatallrawdatageneratedarefullydocumentedandrecorded
g)Ensurethatcomputerisedsystemsusedinthestudyhavebeenvalidated
h)Signanddatethefinalreporttoindicateacceptanceofresponsibilityforthevalidityofthedataandtoindicatethe
extenttowhichthestudycomplieswiththesePrinciplesofGoodLaboratoryPractice
i) Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and
supportingmaterialarearchived.
1.3PrincipalInvestigator'sResponsibilities
The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable
PrinciplesofGoodLaboratoryPractice.
1.4StudyPersonnel'sResponsibilities
1. All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good
LaboratoryPracticewhichareapplicabletotheirinvolvementinthestudy.
2. Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their
involvementinthestudy.Itistheirresponsibilitytocomplywiththeinstructionsgiveninthesedocuments.Anydeviationfrom
these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal
Investigator(s).
3.AllstudypersonnelareresponsibleforrecordingrawdatapromptlyandaccuratelyandincompliancewiththesePrinciples
ofGoodLaboratoryPractice,andareresponsibleforthequalityoftheirdata.
4.Studypersonnelshouldexercisehealthprecautionstominimiserisktothemselvesandtoensuretheintegrityofthestudy.
They should communicate to the appropriate person any relevant known health or medical condition in order that they can be
excludedfromoperationsthatmayaffectthestudy.
2.QualityAssuranceProgramme
2.1General
1. The test facility should have a documented Quality Assurance Programme to assure that studies performed are in
compliancewiththesePrinciplesofGoodLaboratoryPractice.
2. The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly
responsibletomanagementandwhoarefamiliarwiththetestprocedures.
3.Thisindividual(s)shouldnotbeinvolvedintheconductofthestudybeingassured.
2.2ResponsibilitiesoftheQualityAssurancePersonnel
1.TheresponsibilitiesoftheQualityAssurancepersonnelinclude,butarenotlimitedto,thefollowingfunctions.Theyshould:
a)MaintaincopiesofallapprovedstudyplansandStandardOperatingProceduresinuseinthetestfacilityandhave
accesstoanuptodatecopyofthemasterschedule
b)VerifythatthestudyplancontainstheinformationrequiredforcompliancewiththesePrinciplesofGoodLaboratory
Practice.Thisverificationshouldbedocumented
c) Conduct inspections to determine if all studies are conducted in accordance with these Principles of Good
LaboratoryPractice.InspectionsshouldalsodeterminethatstudyplansandStandardOperatingProcedureshavebeen
madeavailabletostudypersonnelandarebeingfollowed.
InspectionscanbeofthreetypesasspecifiedbyQualityAssuranceProgrammeStandardOperatingProcedures:
Studybasedinspections,
Facilitybasedinspections,
Processbasedinspections.
Recordsofsuchinspectionsshouldberetained.
d)Inspectthefinalreportstoconfirmthatthemethods,procedures,andobservationsareaccuratelyandcompletely
described,andthatthereportedresultsaccuratelyandcompletelyreflecttherawdataofthestudies
e) Promptly report any inspection results in writing to management and to the Study Director, and to the Principal
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Investigator(s)andtherespectivemanagement,whenapplicable
f) Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their
dates,includingthephase(s)ofthestudyinspected,andthedatesinspectionresultswerereportedtomanagementand
theStudyDirectorandPrincipalInvestigator(s),ifapplicable.Thisstatementwouldalsoservetoconfirmthatthefinal
reportreflectstherawdata.
3.Facilities
3.1General
1.Thetestfacilityshouldbeofsuitablesize,constructionandlocationtomeettherequirementsofthestudyandtominimise
disturbancethatwouldinterferewiththevalidityofthestudy.
2.Thedesignofthetestfacilityshouldprovideanadequatedegreeofseparationofthedifferentactivitiestoassuretheproper
conductofeachstudy.
3.2TestSystemFacilities
1.Thetestfacilityshouldhaveasufficientnumberofroomsorareastoassuretheisolationoftestsystemsandtheisolation
ofindividualprojects,involvingsubstancesororganismsknowntobeorsuspectedofbeingbiohazardous.
2. Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that
thereisnounacceptabledegreeofdeteriorationoftestsystems.
3.Thereshouldbestorageroomsorareasasneededforsuppliesandequipment.Storageroomsorareasshouldbeseparated
fromroomsorareashousingthetestsystemsandshouldprovideadequateprotectionagainstinfestation,contamination,and/or
deterioration.
3.3FacilitiesforHandlingTestandReferenceItems
1. To prevent contamination or mixups, there should be separate rooms or areas for receipt and storage of the test and
referenceitems,andmixingofthetestitemswithavehicle.
2.Storageroomsorareasforthetestitemsshouldbeseparatefromroomsorareascontainingthetestsystems.Theyshould
beadequatetopreserveidentity,concentration,purity,andstability,andensuresafestorageforhazardoussubstances.
3.4ArchiveFacilities
Archivefacilitiesshouldbeprovidedforthesecurestorageandretrievalofstudyplans,rawdata,finalreports,samplesoftest
itemsandspecimens.Archivedesignandarchiveconditionsshouldprotectcontentsfromuntimelydeterioration.
3.5WasteDisposal
Handlinganddisposalofwastesshouldbecarriedoutinsuchawayasnottojeopardisetheintegrityofstudies.Thisincludes
provisionforappropriatecollection,storageanddisposalfacilities,anddecontaminationandtransportationprocedures.
4.Apparatus,Material,andReagents
1. Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for
controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate
capacity.
2. Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard
OperatingProcedures.Recordsoftheseactivitiesshouldbemaintained.Calibrationshould,whereappropriate,betraceableto
nationalorinternationalstandardsofmeasurement.
3.Apparatusandmaterialsusedinastudyshouldnotinterfereadverselywiththetestsystems.
4.Chemicals,reagents,andsolutionsshouldbelabelledtoindicateidentity(withconcentrationifappropriate),expirydateand
specificstorageinstructions.Informationconcerningsource,preparationdateandstabilityshouldbeavailable.Theexpirydate
maybeextendedonthebasisofdocumentedevaluationoranalysis.
5.TestSystems
5.1Physical/Chemical
1. Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and
adequatecapacity.
2.Theintegrityofthephysical/chemicaltestsystemsshouldbeensured.
5.2Biological
1. Proper conditions should be established and maintained for the storage, housing, handling and care of biological test
systems,inordertoensurethequalityofthedata.
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2.Newlyreceivedanimalandplanttestsystemsshouldbeisolateduntiltheirhealthstatushasbeenevaluated.Ifanyunusual
mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At
theexperimentalstartingdateofastudy,testsystemsshouldbefreeofanydiseaseorconditionthatmightinterferewiththe
purposeorconductofthestudy.Testsystemsthatbecomediseasedorinjuredduringthecourseofastudyshouldbeisolated
andtreated,ifnecessarytomaintaintheintegrityofthestudy.Anydiagnosisandtreatmentofanydiseasebeforeorduringa
studyshouldberecorded.
3.Recordsofsource,dateofarrival,andarrivalconditionoftestsystemsshouldbemaintained.
4. Biological test systems should be acclimatised to the test environment for an adequate period before the first
administration/applicationofthetestorreferenceitem.
5. All information needed to properly identify the test systems should appear on their housing or containers. Individual test
systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate
identification,whereverpossible.
6.Duringuse,housingorcontainersfortestsystemsshouldbecleanedandsanitised at appropriate intervals. Any material
that comes into contact with the test system should be free of contaminants at levels that would interfere with the study.
Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be
documented.
7.Testsystemsusedinfieldstudiesshouldbelocatedsoastoavoidinterferenceinthestudyfromspraydriftandfrompast
usageofpesticides.
6.TestandReferenceItems
6.1Receipt,Handling,SamplingandStorage
1.Recordsincludingtestitemandreferenceitemcharacterisation,dateofreceipt,expirydate,quantitiesreceivedandusedin
studiesshouldbemaintained.
2.Handling,sampling,andstorageproceduresshouldbeidentifiedinorderthatthehomogeneityandstabilityareassuredto
thedegreepossibleandcontaminationormixupareprecluded.
3.Storagecontainer(s)shouldcarryidentificationinformation,expirydate,andspecificstorageinstructions.
6.2Characterisation
1.Each test and reference item should be appropriately identified (e.g., code, Chemical Abstracts Service Registry Number
[CASnumber],name,biologicalparameters).
2. For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to
appropriatelydefineeachbatchofthetestorreferenceitemsshouldbeknown.
3.Incaseswherethetestitemissuppliedbythesponsor,thereshouldbeamechanism,developedincooperationbetween
thesponsorandthetestfacility,toverifytheidentityofthetestitemsubjecttothestudy.
4.Thestabilityoftestandreferenceitemsunderstorageandtestconditionsshouldbeknownforallstudies.
5.Ifthetestitemisadministeredorappliedinavehicle,thehomogeneity,concentrationandstabilityofthetestiteminthat
vehicleshouldbedetermined.Fortestitemsusedinfieldstudies(e.g.,tankmixes)thesemaybedeterminedthroughseparate
laboratoryexperiments.
6.Asampleforanalyticalpurposesfromeachbatchoftestitemshouldberetainedforallstudiesexceptshorttermstudies.
7.StandardOperatingProcedures
7.1.AtestfacilityshouldhavewrittenStandardOperatingProceduresapprovedbytestfacilitymanagementthatareintended
toensurethequalityandintegrityofthedatageneratedbythattestfacility.RevisionstoStandardOperatingProceduresshould
beapprovedbytestfacilitymanagement.
7.2.EachseparatetestfacilityunitorareashouldhaveimmediatelyavailablecurrentStandardOperatingProceduresrelevant
to the activities being performed therein. Published text books, analytical methods, articles and manuals may be used as
supplementstotheseStandardOperatingProcedures.
7.3.DeviationsfromStandardOperatingProceduresrelatedtothestudyshouldbedocumentedandshouldbeacknowledged
bytheStudyDirectorandthePrincipalInvestigator(s),asapplicable.
7.4. Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility
activities.Thedetailsgivenundereachheadingaretobeconsideredasillustrativeexamples.
1.TestandReferenceItems
Receipt,identification,labelling,handling,samplingandstorage.
2.Apparatus,MaterialsandReagents
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a)Apparatus:use,maintenance,cleaningandcalibration
b)ComputerisedSystems:validation,operation,maintenance,security,changecontrolandbackup
c)Materials,ReagentsandSolutions:preparationandlabelling
3.RecordKeeping,Reporting,Storage,andRetrieval
Coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of
computerisedsystems.
4.TestSystem(whereappropriate)
a)Roompreparationandenvironmentalroomconditionsforthetestsystem.
b) Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test
system.
c)Testsystempreparation,observationsandexaminations,before,duringandattheconclusionofthestudy.
d)Handlingoftestsystemindividualsfoundmoribundordeadduringthestudy.
e)Collection,identificationandhandlingofspecimensincludingnecropsyandhistopathology.
f)Sitingandplacementoftestsystemsintestplots.
5.QualityAssuranceProcedures
OperationofQualityAssurancepersonnelinplanning,scheduling,performing,documentingandreportinginspections.
8.PerformanceoftheStudy
8.1StudyPlan
1.Foreachstudy,awrittenplanshouldexistpriortotheinitiationofthestudy.Thestudyplanshouldbeapprovedbydated
signatureoftheStudyDirectorandverifiedforGLPcompliancebyQualityAssurancepersonnelasspecifiedinSection2.2.1.b.,
above. The study plan should also be approved by the test facility management and the sponsor, if required by national
regulationorlegislationinthecountrywherethestudyisbeingperformed.
2.a)AmendmentstothestudyplanshouldbejustifiedandapprovedbydatedsignatureoftheStudyDirectorandmaintained
withthestudyplan.
b)Deviationsfromthestudyplanshouldbedescribed,explained,acknowledgedanddatedinatimelyfashionbytheStudy
Directorand/orPrincipalInvestigator(s)andmaintainedwiththestudyrawdata.
3.Forshorttermstudies,ageneralstudyplanaccompaniedbyastudyspecificsupplementmaybeused.
8.2ContentoftheStudyPlan
Thestudyplanshouldcontain,butnotbelimitedtothefollowinginformation:
1.IdentificationoftheStudy,theTestItemandReferenceItem
a)Adescriptivetitle
b)Astatementwhichrevealsthenatureandpurposeofthestudy
c)Identificationofthetestitembycodeorname(IUPACCASnumber,biologicalparameters,etc.)
d)Thereferenceitemtobeused.
2.InformationConcerningtheSponsorandtheTestFacility
a)Nameandaddressofthesponsor
b)Nameandaddressofanytestfacilitiesandtestsitesinvolved
c)NameandaddressoftheStudyDirector
d) Name and address of the Principal Investigator(s), and the phase(s) of the study delegated by the Study
DirectorandundertheresponsibilityofthePrincipalInvestigator(s).
3.Dates
a)ThedateofapprovalofthestudyplanbysignatureoftheStudyDirector.Thedateofapprovalofthestudy
planbysignatureofthetestfacilitymanagementandsponsorifrequiredbynationalregulationorlegislationinthe
countrywherethestudyisbeingperformed.
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b)Theproposedexperimentalstartingandcompletiondates.
4.TestMethods
ReferencetotheOECDTestGuidelineorothertestguidelineormethodtobeused.
5.Issues(whereapplicable)
a)Thejustificationforselectionofthetestsystem
b)Characterisationofthetestsystem,suchasthespecies,strain,substrain,sourceofsupply,number,body
weightrange,sex,ageandotherpertinentinformation
c)Themethodofadministrationandthereasonforitschoice
d)Thedoselevelsand/orconcentration(s),frequency,anddurationofadministration/application
e)Detailedinformationontheexperimentaldesign,includingadescriptionofthechronologicalprocedureofthe
study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and
examinationstobeperformed,andstatisticalmethodstobeused(ifany).
6.Records
Alistofrecordstoberetained.
8.3ConductoftheStudy
1. A unique identification should be given to each study. All items concerning this study should carry this identification.
Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as
appropriateforthespecimenandstudy.
2.Thestudyshouldbeconductedinaccordancewiththestudyplan.
3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the
individualenteringthedata.Theseentriesshouldbesignedorinitialledanddated.
4.Anychangeintherawdatashouldbemadesoasnottoobscurethepreviousentry,shouldindicatethereasonforchange
andshouldbedatedandsignedorinitialledbytheindividualmakingthechange.
5.Datageneratedasadirectcomputerinputshouldbeidentifiedatthetimeofdatainputbytheindividual(s)responsiblefor
directdataentries.Computerisedsystemdesignshouldalwaysprovidefortheretentionoffullaudittrailstoshowallchangesto
thedatawithoutobscuringtheoriginaldata.Itshouldbepossibletoassociateallchangestodatawiththepersonshavingmade
thosechanges,forexample,byuseoftimedanddated(electronic)signatures.Reasonforchangesshouldbegiven.
9.ReportingofStudyResults
9.1General
1.Afinalreportshouldbepreparedforeachstudy.Inthecaseofshorttermstudies,astandardisedfinalreportaccompanied
byastudyspecificextensionmaybeprepared.
2.ReportsofPrincipalInvestigatorsorscientistsinvolvedinthestudyshouldbesignedanddatedbythem.
3.ThefinalreportshouldbesignedanddatedbytheStudyDirectortoindicateacceptanceofresponsibilityforthevalidityof
thedata.TheextentofcompliancewiththesePrinciplesofGoodLaboratoryPracticeshouldbeindicated.
4.Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the
reasonforthecorrectionsoradditionsandshouldbesignedanddatedbytheStudyDirector.
5.Reformattingofthefinalreporttocomplywiththesubmissionrequirementsofanationalregistrationorregulatoryauthority
doesnotconstituteacorrection,additionoramendmenttothefinalreport.
9.2ContentoftheFinalReport
Thefinalreportshouldinclude,butnotbelimitedto,thefollowinginformation:
1.IdentificationoftheStudy,theTestItemandReferenceItem
a)Adescriptivetitle
b)Identificationofthetestitembycodeorname(IUPAC,CASnumber,biologicalparameters,etc.)
c)Identificationofthereferenceitembyname
d)Characterisationofthetestitemincludingpurity,stabilityandhomogeneity.
2.InformationConcerningtheSponsorandtheTestFacility
http://webnet.oecd.org/OECDACTS/Instruments/PrintInstrumentView.aspx?InstrumentID=263&ampInstrumentPID=339&InstrumentHID=0&ampLang=en 10/12
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a)Nameandaddressofthesponsor
b)Nameandaddressofanytestfacilitiesandtestsitesinvolved
c)NameandaddressoftheStudyDirector
d)NameandaddressofthePrincipalInvestigator(s)andthephase(s)ofthestudydelegated,ifapplicable
e)Nameandaddressofscientistshavingcontributedreportstothefinalreport.
3.Dates
Experimentalstartingandcompletiondates.
4.Statement
AQualityAssuranceProgrammestatementlistingthetypesofinspectionsmadeandtheirdates,includingthephase(s)
inspected,andthedatesanyinspectionresultswerereportedtomanagementandtotheStudyDirectorandPrincipal
Investigator(s),ifapplicable.Thisstatementwouldalsoservetoconfirmthatthefinalreportreflectstherawdata.
5.DescriptionofMaterialsandTestMethods
a)Descriptionofmethodsandmaterialsused
b)ReferencetoOECDTestGuidelineorothertestguidelineormethod.
6.Results
a)Asummaryofresults
b)Allinformationanddatarequiredbythestudyplan
c)Apresentationoftheresults,includingcalculationsanddeterminationsofstatisticalsignificance
d)Anevaluationanddiscussionoftheresultsand,whereappropriate,conclusions.
7.Storage
Thelocation(s)wherethestudyplan,samplesoftestandreferenceitems,specimens,rawdataandthefinalreportare
tobestored.
10.StorageandRetentionofRecordsandMaterials
10.1Thefollowingshouldberetainedinthearchivesfortheperiodspecifiedbytheappropriateauthorities:
a)Thestudyplan,rawdata,samplesoftestandreferenceitems,specimens,andthefinalreportofeachstudy
b)RecordsofallinspectionsperformedbytheQualityAssuranceProgramme,aswellasmasterschedules
c)Recordsofqualifications,training,experienceandjobdescriptionsofpersonnel
d)Recordsandreportsofthemaintenanceandcalibrationofapparatus
e)Validationdocumentationforcomputerisedsystems
f)ThehistoricalfileofallStandardOperatingProcedures
g)Environmentalmonitoringrecords.
Intheabsenceofarequiredretentionperiod,thefinaldispositionofanystudymaterialsshouldbedocumented.Whensamples
oftestandreferenceitemsandspecimensaredisposedofbeforetheexpiryoftherequiredretentionperiodforanyreason,this
shouldbejustifiedanddocumented.Samplesoftestandreferenceitemsandspecimensshouldberetainedonlyaslongasthe
qualityofthepreparationpermitsevaluation.
10.2Materialretainedinthearchivesshouldbeindexedsoastofacilitateorderlystorageandretrieval.
10.3Onlypersonnelauthorisedbymanagementshouldhaveaccesstothearchives.Movementofmaterialinandoutofthe
archivesshouldbeproperlyrecorded.
10.4Ifatestfacilityoranarchivecontractingfacilitygoesoutofbusinessandhasnolegalsuccessor,thearchiveshouldbe
transferredtothearchivesofthesponsor(s)ofthestudy(s).
Relevant ManagementCommitteeoftheSpecialProgrammeontheControlofChemicalsnowcalledChemicals
body:
Committee
16/04/2015
Pleasenotethatthisisaprintoutversion.Theonlyofficialanduptodateversionofthislegalinstrumentisavailableonlineat:http://acts.oecd.org

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