1. What is the GLP?

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

3. 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.

4. 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.

5. 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.

6. 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

7. 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

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

9. 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

10. 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

11. 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

12. 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

13. Monitoring Authority
The OECD-member
Israel
South Africa

14. 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