GLP & Quality Assurance หนึ่งฤทัย แสแสงสีรุ้ง กรมวิทยาศาสตร์บริการ30 สิงหาคม 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 GLP = Good Laboratory Practice OECD Principles on Good Laboratory Practice What is the OECD?

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 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

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 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

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

ISO 17025 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

ISO 17025 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

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