Future issues including broadening the scope of the GLP principles.
When the principles of good laboratory practice (GLP) were drafted in 1982 by the Organisation for Economic Cooperation and Development (OECD) the electronic era was in its infant stages and many of the issues surrounding what may affect the environment and human health was not expected. Today, advances in technology for capturing and recording data for the reconstruction of a study are available and are being developed operating at speeds which could not have been known or understood in years past. Since that time, the United States Environmental Protection Agency (EPA) has required the conduct of additional studies in support of a pesticide registration in accordance with the GLP regulations. However, not all of these studies are required in other countries or may not require adherence to the principles of GLP. Companies are using computer models as virtual studies instead of inlife or bench type regulated research. Studies are often conducted at institutions of higher learning because of the academic expertise they offer. What is the overall impact advancing technology has on the principles of GLP? Are monitoring authorities (MAs) ready? The medical products field faces similar issues. Development and testing of these products and devices is being conducted similar to development and testing in the pesticide arena. To garner trust in mutual acceptance of data, each participating country must adhere to practices that ensure the highest standards of quality and integrity. The GLP inspector will need to have a good understanding of the science supporting the study conduct and the electronic systems that generate process and maintain study records.
Laboratory Data Integrity Branch, Environmental Protection Agency, 1200 Pennsylvania Av., NW, Washington, DC 20460, USA. liem.francisca@epa.gov
Francisca E
FE
Liem
Mark J
MJ
Lehr
D019411:Clinical Laboratory Techniques / Q000592:standards*; D005544:Forecasting; D017408:Guidelines as Topic; D020407:Internet; D030781:Organisms, Genetically Modified