1. GLP & Quality Assurance
หนึ่งฤทัย แสแสงสีรุ้ง กรมวิทยาศาสตร์บริการ30 สิงหาคม 2548

2. Relative between REACH and GLP
Safety Data Sheet (SDS)
physico-chemical properties : 20 items
Toxicological studies : 41 items
Ecotoxicological studies : 10 items

3. 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?

4. What is the GLP?

5. GLP GLP = Good Laboratory Practice
OECD Principles on Good Laboratory Practice
What is the OECD?

6. 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.

7. 30 industrialized countries
Australia
Austria
Belgium
Canada
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Japan
Korea
Luxembourg
Mexico
Netherlands
New Zealand
Poland
Portugal
Slovak Republic
Spain
Sweden
Switzerland
Turkey UK
USA
Norway

8. 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.

9. 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.

10. 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

11. 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

12. Why do Thailand’s laboratory need the GLP?

13. 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

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

15. ISO 17025 VS GLP ISO Members The same standard for all ISO
Designed for repetitive studies
Description of Quality System in Quality Manual
OECD Members
Different regulations in different countries
Designed for single studies
Description of Quality System in SOPs

16. ISO 17025 VS GLP General statements for responsibilities of personnel
No specific requirements for storage of records and reports
Very specific responsibilities of personnel
Specific requirements for storage, retention and archiving

17. ISO VS GLP
No study plans required (standardized methods should be used)
Written operating procedures without specific format
Study plan required for each study
SOPs with detailed requirements for format and content

18. ISO VS GLP
Analysis methods must be verified through inter-laboratory test (PT)
Documented complaints procedures
Storage of test samples and data until client accepts results
Validation through inter-laboratory tests not required
In case of problems, only course of law
Storage of test samples according to local regulatory requirements

19. Monitoring Authority
The OECD-member
Israel
South Africa

20. What is the MAD program?

21. 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.

22. 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

23. Conclusion