Performing GLP studies in a traditionally non-GLP facility.
Situations can arise in which traditionally non-GLP facilities may have to be used for performing nonclinical GLP studies or parts of a GLP study. The situations may include a need for particular expertise of scientists, the analytical laboratory, or the development of an unusual product. This article describes the use of a core group model as a proactive strategic plan to bring the traditionally non-GLP facility into compliance before the GLP study is conducted. The core group team is composed of representatives of both the Sponsor and the facility where the GLP study will be conducted. The core group model uses a nine-step plan that fosters good communication, co-operative planning, and adequate preparation before initiation of a proposed GLP nonclinical study, conducted under GLP compliance, at a traditionally non-GLP facility.
Pomerleau
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Chemical Industry Institute of Toxicology, Research Triangle Park, North Carolina 27709-2137.
D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D007753:Laboratories / Q000592:standards*; D008330:Management Audit / Q000379:methods*; D017146:Models, Organizational; D016730:Program Development / Q000379:methods*