GLP & Quality Assurance

หนงฤทย แสแสงสรง กรมวทยาศาสตรบรการ

30 สงหาคม 2548

Relative between REACH and GLP

Safety Data Sheet (SDS)

–physico-chemical properties : 20 items

–Toxicological studies : 41 items

–Ecotoxicological studies : 10 items

Outline

What is the GLP?

Why do Thailand’s laboratory need the

GLP?

What is a difference between GLP & ISO

17025?

What is the MAD program?

What is the GLP?

GLP = Good Laboratory Practice

OECD Principles on Good Laboratory Practice

What is the OECD?

GLP

The Organization for Economic Co-operation and Development : OECD

Intergovernmental organization

30 industrialized countries

Meet to co-ordinate and harmonize policies.

Discuss issues of mutual concern

Work together to respond to international problems.

30 industrialized countries

1. Australia 2. Austria 3. Belgium 4. Canada 5. Czech

Republic 6. Denmark 7. Finland8. France 9. Germany 10. Greece

21.Poland 22.Portugal23. Slovak Republic 24.Spain 25.Sweden26. Switzerland 27.Turkey28. UK 29.USA30. Norway

11. Hungary 12. Iceland 13. Ireland 14. Italy 15. Japan 16. Korea17. Luxembourg 18. Mexico 19. Netherlands 20. New Zealand

The purpose of GLP

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

Definition of GLP

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

Scope of principle of GLP

GLP should be applied to the non-clinical safety testing of test items:

Pharmaceutical product

Pesticides product

Cosmetic product

Food additives

Feed additives

Industrial chemical

in the Laboratory, in greenhouses or in the field

Type of tests

physico-chemical properties

Toxicological studies designed to evaluate human health effects

Ecotoxicological studies designed to evaluate environmental effects

Ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)

Ref.No. 6

Why do Thailand’s laboratory need the GLP?

Type of tests

physico-chemical properties

Toxicological studies designed to evaluate human health effects

Ecotoxicological studies designed to evaluate environmental effects

Ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)

Ref.No. 6

What is a difference between GLP & ISO 17025?

ISO 17025 VS GLP

1. ISO Members

2. The same standard for all ISO

3. Designed for repetitive studies

4. Description of Quality System in Quality Manual

1. OECD Members

2. Different regulations in different countries

3. Designed for single studies

4. Description of Quality System in SOPs

ISO 17025 VS GLP

5. General statements for responsibilities of personnel

6. No specific requirements for storage of records and reports

5. Very specific responsibilities of personnel

6. Specific requirements for storage, retention and archiving

ISO 17025 VS GLP

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

8. Written operating procedures without specific format

7. Study plan required for each study

8. SOPs with detailed requirements for format and content

ISO 17025 VS GLP

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

10.Documented complaints procedures

11.Storage of test samples and data until client accepts results

9. Validation through inter-laboratory tests not required

10.In case of problems, only course of law

11.Storage of test samples according to local regulatory requirements

Monitoring Authority

The OECD-member

Israel

South Africa

What is the MAD program?

MAD

The Mutual Acceptance of Data

1981 : Council Decision on the Mutual Assessment of Data in the Assessment of Chemicals( revised 1997)

1989 : Establishment of national compliance monitoring programmes

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

OECD Series on Principles of GLP and Compliance Monitoring

OECD Principles of GLP: No.1

Guidance Documents for Compliance Monitoring Authorities : No.2, 3 & 9

Consensus Documents : No.5-8, 10 & 13

Advisory Documents of the Working Group on GLP : No.11, 12 & 14

http://www.oecd.org

Conclusion