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.

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

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

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 & Consensus Documents : No.5-8, 10 &

1313Advisory 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