Good Laboratory Practice in Drug Development
(Non-Clinical Laboratory Studies)

The requirement for Good Laboratory Practice (GLP) is intended to promote the quality and validity of test data. In fact, the GLP regulations for non-clinical laboratory studies, published by the US Food & Drug Administration, have provided the basis for guidelines and regulations throughout the world. It is the application of the GLPs that is of crucial importance to national authorities entrusted with the responsibility of assessing test data and evaluating material safety data The latest international publication relating to the practice and compliance aspects of GLP was published in 1992, by the Organization for Economic Co-Operation and Development (OECD).

This publication of the Principles of Good Laboratory Practice was developed in an Expert Group, with the participation of many countries and organizations, including the UK, US, WHO, ISO/Certico and Canada. The original OECD Principles of GLP were first published in 1982 (out of print), and the current version is available as Monograph No. 45.

This course will deal with the following content:

1. Definition of Terms	8. Test Facility Organization
2. Quality assurance Programme	9. Facilities
3. Apparatus	10. Test Systems
4. Test and Reference Substances	11. Standard Operating Procedures
5. Performance of Study	12. Reporting of Study Results
6. Storage and Retention of Records	13. Auditing
7. References/Regulations//Guideline