GLP & Quality Assurance

30 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 Thailands laboratory need the GLP? What is a difference between GLP & ISO 17025? What is the MAD program?

What is the GLP?

GLP

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

The Organization for Economic Cooperation 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
Australia Austria 3. Belgium 4. Canada 5. Czech Republic 6. Denmark 7. Finland 8. France 9. Germany 10. Greece
1. 2.

Hungary Iceland 13. Ireland 14. Italy 15. Japan 16. Korea 17. Luxembourg 18. Mexico 19. Netherlands 20. New Zealand
11. 12.

21.Poland

22.Portugal 23. Slovak Republic 24.Spain 25.Sweden 26. Switzerland 27.Turkey 28. UK 29.USA 30. Norway

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 Thailands 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
1. ISO Members 2. The same standard for all ISO 3. Designed for repetitive studies 4. Description of Quality System in Quality Manual

VS

GLP

1. OECD Members 2. Different regulations in different countries 3. Designed for single studies 4. Description of Quality System in SOPs

ISO 17025
5. General statements for responsibilities of personnel 6. No specific requirements for storage of records and reports

VS

GLP

5. Very specific responsibilities of personnel 6. Specific requirements for storage, retention and archiving

ISO 17025
7. No study plans required (standardized methods should be used) 8. Written operating procedures without specific format

VS

GLP

7. Study plan required for each study

8. SOPs with detailed requirements for format and content

ISO 17025
9. Analysis methods must be verified through interlaboratory test (PT) 10.Documented complaints procedures 11.Storage of test samples and data until client accepts results

VS

GLP

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