GLP & Quality AssuranceGLP & Quality Assurance

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Relative between REACH and Relative between REACH and GLPGLP

Safety Data Sheet (SDS)Safety Data Sheet (SDS)

– physico-chemical properties : 20 physico-chemical properties : 20 itemsitems

– Toxicological studies : 41 itemsToxicological studies : 41 items

– Ecotoxicological studies : 10 itemsEcotoxicological studies : 10 items

OutlineOutline

What is the GLP?What is the GLP? Why do Thailand’s laboratory need Why do Thailand’s laboratory need

the GLP?the GLP? What is a difference between GLP & What is a difference between GLP &

ISO 17025?ISO 17025? What is the MAD program?What is the MAD program?

What is the GLP?What is the GLP?

GLP = GLP = GGood ood LLaboratory aboratory PPracticeractice OECD Principles on Good OECD Principles on Good

Laboratory PracticeLaboratory Practice What is the OECD?What is the OECD?

GLPGLP

The Organization for Economic Co- The Organization for Economic Co- operation and Development : operation and Development :

OECDOECD

Intergovernmental organizationIntergovernmental organization 30 industrialized countries30 industrialized countries Meet to co-ordinate and harmonize Meet to co-ordinate and harmonize

policies.policies. Discuss issues of mutual concernDiscuss issues of mutual concern Work together to respond to international Work together to respond to international

problems.problems.

30 industrialized countries30 industrialized countries

1.1. Australia Australia 2.2. Austria Austria 3.3. Belgium Belgium 4.4. Canada Canada 5.5. Czech Czech

Republic Republic 6.6. Denmark Denmark 7.7. FinlandFinland8.8. France France 9.9. Germany Germany 10.10.GreeceGreece

21.21.Poland Poland 22.22.PortugalPortugal23.23. Slovak Slovak

Republic Republic 24.24.Spain Spain 25.25.SwedenSweden26.26. Switzerland Switzerland 27.27.TurkeyTurkey28.28. UK UK 29.29.USAUSA30.30. Norway Norway

11.11. Hungary Hungary 12.12. Iceland Iceland 13.13. Ireland Ireland 14.14. Italy Italy 15.15. Japan Japan 16.16. KoreaKorea17.17. Luxembourg Luxembourg 18.18. Mexico Mexico 19.19. Netherlands Netherlands 20.20. New ZealandNew Zealand

The purpose of GLPThe purpose of GLP

The principle of Good laboratory The principle of Good laboratory practice (GLP) : to promote the practice (GLP) : to promote the development of quality and validity development of quality and validity of test data used for determining the of test data used for determining the safety of chemicals and chemicals safety of chemicals and chemicals product.product.

Definition of GLPDefinition of GLP

GLP is a quality system concerned GLP is a quality system concerned with the organizational process and with the organizational process and the conditions under which non-the conditions under which non-clinical health and environmental clinical health and environmental safety studies are safety studies are planned, planned, performed, monitored, recorded, performed, monitored, recorded, archived and reportedarchived and reported..

Scope of principle of GLPScope of principle of GLP GLP should be applied to the non-clinical GLP should be applied to the non-clinical

safety testing of test items:safety testing of 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

Type of testsType of tests

physico-chemical propertiesphysico-chemical properties Toxicological studies designed to Toxicological studies designed to

evaluate human health effectsevaluate human health effects Ecotoxicological studies designed to Ecotoxicological studies designed to

evaluate environmental effectsevaluate environmental effects Ecological studies designed to evaluate Ecological studies designed to evaluate

environmental chemical fate (transport, environmental chemical fate (transport, biodegradation, and bioaccumulation)biodegradation, and bioaccumulation)

Ref.No. 6Ref.No. 6

Why do Thailand’s Why do Thailand’s laboratory need the laboratory need the

GLP?GLP?

Type of testsType of tests

physico-chemical propertiesphysico-chemical properties Toxicological studies designed to Toxicological studies designed to

evaluate human health effectsevaluate human health effects Ecotoxicological studies designed to Ecotoxicological studies designed to

evaluate environmental effectsevaluate environmental effects Ecological studies designed to evaluate Ecological studies designed to evaluate

environmental chemical fate (transport, environmental chemical fate (transport, biodegradation, and bioaccumulation)biodegradation, and bioaccumulation)

Ref.No. 6Ref.No. 6

What is a difference What is a difference between GLP & ISO 17025?between GLP & ISO 17025?

ISO 17025 ISO 17025 VSVS GLP GLP

1.1. ISO MembersISO Members

2.2. The same The same standard for all standard for all ISOISO

3.3. Designed for Designed for repetitive studiesrepetitive studies

4.4. Description of Description of Quality System in Quality System in Quality ManualQuality Manual

1.1. OECD MembersOECD Members

2.2. Different Different regulations in regulations in different countriesdifferent countries

3.3. Designed for Designed for single studiessingle studies

4.4. Description of Description of Quality System in Quality System in SOPsSOPs

ISO 17025 ISO 17025 VSVS GLP GLP

5.5. General General statements for statements for responsibilities of responsibilities of personnelpersonnel

6.6. No specific No specific requirements for requirements for storage of records storage of records and reportsand reports

5.5. Very specific Very specific responsibilities of responsibilities of personnelpersonnel

6.6. Specific Specific requirements for requirements for storage, retention storage, retention and archivingand archiving

ISO 17025 ISO 17025 VSVS GLP GLP

7.7. No study plans No study plans required required (standardized (standardized methods should methods should be used)be used)

8.8. Written operating Written operating procedures procedures without specific without specific formatformat

7.7. Study plan Study plan required for each required for each studystudy

8.8. SOPs with SOPs with detailed detailed requirements for requirements for format and format and contentcontent

ISO 17025 ISO 17025 VSVS GLP GLP

9.9. Analysis methods Analysis methods must be verified must be verified through inter-through inter-laboratory test (PT)laboratory test (PT)

10.10. Documented Documented complaints complaints proceduresprocedures

11.11. Storage of test Storage of test samples and data samples and data until client accepts until client accepts resultsresults

9.9. Validation through Validation through inter-laboratory inter-laboratory tests not requiredtests not required

10.10. In case of In case of problems, only problems, only course of lawcourse of law

11.11. Storage of test Storage of test samples according samples according to local regulatory to local regulatory requirementsrequirements

Monitoring Authority Monitoring Authority

The OECD-memberThe OECD-member IsraelIsrael South AfricaSouth Africa

What is the MAD What is the MAD program?program?

MADMAD

The Mutual Acceptance of DataThe Mutual Acceptance of Data 1981 : Council Decision on the Mutual 1981 : Council Decision on the Mutual

Assessment of Data in the Assessment Assessment of Data in the Assessment of Chemicals( revised 1997)of Chemicals( revised 1997)

1989 : Establishment of national 1989 : Establishment of national compliance monitoring programmes compliance monitoring programmes

1997: non-OECD countries can adhere 1997: non-OECD countries can adhere to the MAD system.to the MAD system.

OECD Series on Principles of GLP OECD Series on Principles of GLP and Compliance Monitoringand Compliance Monitoring

OECD Principles of GLP: No.1OECD Principles of GLP: No.1Guidance Documents for Compliance Guidance Documents for Compliance

Monitoring Authorities : No.2, 3 & 9Monitoring Authorities : No.2, 3 & 9Consensus Documents : No.5-8, 10 & 13Consensus Documents : No.5-8, 10 & 13Advisory Documents of the Working Advisory Documents of the Working

Group on GLP : No.11, 12 & 14Group on GLP : No.11, 12 & 14

http://www.oecd.orghttp://www.oecd.org

ConclusionConclusion