OECD principles of GLP: what is working and what needs work.
The Organisation for Economic Co-operation and Development (OECD) principles of good laboratory practice (GLP) are intended to assure data quality and integrity. The pre-clinical safety data generated in an OECD member country in accordance with the principles of GLP are indeed accepted in other member countries for purposes of assessment. Regulatory authorities (RA) routinely further assess such studies to determine their applicability to specific regulatory decisions. In the experience of the author, the procedures laid out by the OECD GLP principles often support and complement the collection of robust data and aptly address complexities such as multisite study conduct. Perspectives on what works and what might benefit by further optimization are discussed.
Viswanathan
Chidambaram T
CT
Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, l Silver Spring, Maryland 20993, USA. ct.viswanathan@fda.hhs.gov
D019411:Clinical Laboratory Techniques / Q000592:standards*; D004467:Economics; D007390:International Agencies; D014481:United States; D014486:United States Food and Drug Administration