2. Relative between REACH and GLPRelative between REACH and GLP
Safety Data Sheet (SDS)Safety Data Sheet (SDS)
– physico-chemical properties : 20 itemsphysico-chemical properties : 20 items
– Toxicological studies : 41 itemsToxicological studies : 41 items
– Ecotoxicological studies : 10 itemsEcotoxicological studies : 10 items
3. OUTLINEOUTLINE
What is the GLP?What is the GLP?
Why do Thailand’s laboratory need the GLP?Why do Thailand’s laboratory need the GLP?
What is a difference between GLP & ISO 17025?What is a difference between GLP & ISO 17025?
What is the MAD program?What is the MAD program?
5. GLP =GLP = GGoodood LLaboratoryaboratory PPracticeractice
OECD Principles on Good Laboratory PracticeOECD Principles on Good Laboratory Practice
What is the OECD?What is the OECD?
GLPGLP
6. The Organization for Economic Co- operation andThe Organization for Economic Co- operation and
Development : OECDDevelopment : OECD
Intergovernmental organizationIntergovernmental organization
30 industrialized countries30 industrialized countries
Meet to co-ordinate and harmonize policies.Meet to co-ordinate and harmonize policies.
Discuss issues of mutual concernDiscuss issues of mutual concern
Work together to respond to international problems.Work together to respond to international problems.
8. The purpose of GLPThe purpose of GLP
The principle of Good laboratory practice (GLP) : toThe principle of Good laboratory practice (GLP) : to
promote the development of quality and validity ofpromote the development of quality and validity of
test data used for determining the safety of chemicalstest data used for determining the safety of chemicals
and chemicals product.and chemicals product.
9. Definition of GLPDefinition of GLP
GLP is a quality system concerned with theGLP is a quality system concerned with the
organizational process and the conditions underorganizational process and the conditions under
which non-clinical health and environmental safetywhich non-clinical health and environmental safety
studies arestudies are planned, performed, monitored, recorded,planned, performed, monitored, recorded,
archived and reportedarchived and reported..
10. Scope of principle of GLPScope of principle of GLP
GLP should be applied to the non-clinical safety testing ofGLP should be applied to the non-clinical safety testing of
test items:test items:
Pharmaceutical productPharmaceutical product
Pesticides productPesticides product
Cosmetic productCosmetic product
Food additivesFood additives
Feed additivesFeed additives
Industrial chemicalIndustrial chemical
in the Laboratory, in greenhouses or in the fieldin the Laboratory, in greenhouses or in the field
11. Type of testsType of tests
physico-chemical propertiesphysico-chemical properties
Toxicological studies designed to evaluate human healthToxicological studies designed to evaluate human health
effectseffects
Ecotoxicological studies designed to evaluate environmentalEcotoxicological studies designed to evaluate environmental
effectseffects
Ecological studies designed to evaluate environmentalEcological studies designed to evaluate environmental
chemical fate (transport, biodegradation, and bioaccumulation)chemical fate (transport, biodegradation, and bioaccumulation)
12. Why do Thailand’s laboratory need theWhy do Thailand’s laboratory need the
GLP?GLP?
13. Type of testsType of tests
physico-chemical propertiesphysico-chemical properties
Toxicological studies designed to evaluate human healthToxicological studies designed to evaluate human health
effectseffects
Ecotoxicological studies designed to evaluate environmentalEcotoxicological studies designed to evaluate environmental
effectseffects
Ecological studies designed to evaluate environmentalEcological studies designed to evaluate environmental
chemical fate (transport, biodegradation, and bioaccumulation)chemical fate (transport, biodegradation, and bioaccumulation)
14. What is a difference between GLP & ISOWhat is a difference between GLP & ISO
17025?17025?
15. ISO 17025ISO 17025 VSVS GLPGLP
1.1. ISO MembersISO Members
2.2. The same standard for allThe same standard for all
ISOISO
3.3. Designed for repetitiveDesigned for repetitive
studiesstudies
4.4. Description of QualityDescription of Quality
System in Quality ManualSystem in Quality Manual
1.1. OECD MembersOECD Members
2.2. Different regulations inDifferent regulations in
different countriesdifferent countries
3.3. Designed for single studiesDesigned for single studies
4.4. Description of QualityDescription of Quality
System in SOPsSystem in SOPs
16. ISO 17025ISO 17025 VSVS GLPGLP
5.5. General statements forGeneral statements for
responsibilities ofresponsibilities of
personnelpersonnel
6.6. No specific requirementsNo specific requirements
for storage of records andfor storage of records and
reportsreports
7.7. No study plans requiredNo study plans required
(standardized methods(standardized methods
should be used)should be used)
8.8. Written operatingWritten operating
procedures withoutprocedures without
specific formatspecific format
5.5. Very specificVery specific
responsibilities ofresponsibilities of
personnelpersonnel
6.6. Specific requirements forSpecific requirements for
storage, retention andstorage, retention and
archivingarchiving
7.7. Study plan required forStudy plan required for
each studyeach study
8.8. SOPs with detailedSOPs with detailed
requirements for formatrequirements for format
and contentand content
17. ISO 17025ISO 17025 VSVS GLPGLP
9.9. Analysis methodsAnalysis methods
must be verifiedmust be verified
through inter-through inter-
laboratory test (PT)laboratory test (PT)
10.10. DocumentedDocumented
complaintscomplaints
proceduresprocedures
11.11. Storage of testStorage of test
samples and datasamples and data
until client acceptsuntil client accepts
resultsresults
9.9. Validation throughValidation through
inter-laboratory testsinter-laboratory tests
not requirednot required
10.10. In case of problems,In case of problems,
only course of lawonly course of law
11.11. Storage of testStorage of test
samples accordingsamples according
to local regulatoryto local regulatory
requirementsrequirements
19. What is the MAD program?What is the MAD program?
20. MADMAD
The Mutual Acceptance of DataThe Mutual Acceptance of Data
1981 : Council Decision on the Mutual Assessment of Data in1981 : Council Decision on the Mutual Assessment of Data in
the Assessment of Chemicals( revised 1997)the Assessment of Chemicals( revised 1997)
1989 : Establishment of national compliance monitoring1989 : Establishment of national compliance monitoring
programmesprogrammes
1997: non-OECD countries can adhere to the MAD system.1997: non-OECD countries can adhere to the MAD system.
21. OECD Series on Principles of GLP and ComplianceOECD Series on Principles of GLP and Compliance
MonitoringMonitoring
OECD Principles of GLP: No.1OECD Principles of GLP: No.1
Guidance Documents for Compliance Monitoring Authorities :Guidance Documents for Compliance Monitoring Authorities :
No.2, 3 & 9No.2, 3 & 9
Consensus Documents : No.5-8, 10 & 13Consensus Documents : No.5-8, 10 & 13
Advisory Documents of the Working Group on GLP : No.11,Advisory Documents of the Working Group on GLP : No.11,
12 & 1412 & 14
http://www.oecd.orghttp://www.oecd.org
