Principles on Good Laboratory Practice : OECD 1
This eLearning module is to understand, the importance of good laboratory practice (GLP) in pharmaceutical/biotech industry, in the areas of non-clinical health and environment safety
Role and responsibilities of the sponsor, test facility management, quality assurance team, and other personnel involved in a test study
Basic principles of GLP as per OECD (Organization for economic co-operation and development) and USFDA
Good Laboratory Practice (GLP)– the requirement
Objectives and concepts of GLP
Test and Reference Items
Conducting a study as per GLP
Conduct of the Study
Why it matters
GLP applies to all non-clinical health and environmental safety studies conducted for the purpose of registering or licensing of pharmaceuticals, cosmetics, food additives, veterinary drug products and other similar chemicals. GLP ensures that the data submitted is a true reflection of the results obtained in the lab. It also ensures traceability, reliability, validity, and quality of the test data, thereby aiding non-clinical health and environment safety.
Who is it for
This module is designed for all personnel involved in GLP test facility including those who support GLP activities.