Good Laboratory Practice - GLP and The OECD

GLP and The OECD

Following Decision C(97),186/Final of the OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries. OECD: EMV/MC/CHEM(98)17 part two

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

GLP principles include

1. Organization and Personnel
   • Management-Responsibilities
   • Sponsor-Responsibilities
   • Study Director-Responsibilities
   • Principal Investigator-Responsibilities
   • Study Personnel-Responsibilities
2. Quality assurance program
   • Quality Assurance Personnel
3. Facilities
   • Test System Facilities
   • Facilities for Test and Reference Items
4. Equipment, reagents and Materials
5. Test systems
   • Physical/Chemical
   • Biological
6. Test & Reference items
7. Standard operating procedures
8. Performance of Study
   • Study Plan
   • Conduct of Study
9. Reporting of results
10. Storage of Records and Reports