- Published: 18 September 2009
The Principles of GLP are applied to the conduct of non-clinical health and environmental safety studies of test items contained in various chemical products. A study covers work done in a laboratory, in an animal house, in greenhouses, and in the field. The Principles of GLP do not apply to clinical studies (including pharmaco-kinetic and efficacy studies). Non-clinical studies may cover physico-chemical testing; toxicity, mutagenicity; environmental toxicity; bioaccumulation and residue studies; studies of effect on mesocosms and ecosystems; and the analytical chemistry associated with such studies.
GLP is a quality system concerned with the organisational process and the conditions under which non-clinical studies are planned, performed, recorded, archived and reported. It does not concern itself with the technical validity of the studies themselves. This aspect of a study is evaluated by the registration (receiving) authority. The Principles can be quite prescriptive about some aspects of the conduct of the studies, especially in relation to the role of the Study Director (and any Principal Investigators), the role of the Quality Assurance unit, the documenting of Standard Operating Procedures (SOPs), the content of study plans (protocols) and reports, and the way in which all data related to each study is archived.
Read more about OECD Principles of GLP Recognition.