The environmental protection agency (EPA) published the final rule on EPA good laboratory practice (GLP) standards applicable to any study initiated on or after October 16, 1989. The agency has clearly described the definition of the sponsor, which can be stated as an entity or a person which commissions, provide financial or other resources for a study, submits study to EPA in support of an application for research or marketing permit.<br/>As the GLP study is requested to the test facility from the sponsor side, multiple responsibilities of the sponsor include the characterization details of the test substance along with its stability data plus disclosing all the details of the test substance required for the study conduct, name, address, and communication details for inclusion in the study plan, its approval, signing on the study report, providing safety information on the test substance and retention of records in case if a facility or an archive contracting facility goes out of business thereby notifying the agency in writing. However, the ultimate responsibility for the scientific validity of a study lies with the study director, and not with the sponsor, whose responsibility is to make the decision, based on the outcome of the studies, whether or not to submit a chemical entity for registration to a regulatory authority.<br/>The EPA GLP regulations have also mentioned the additional responsibilities about the studies being conducted or part of it conducted under contracting testing laboratory. Moreover, the presentation will include the detailed responsibilities of the sponsor by citing each reference as mentioned in the regulations as per 40 CFR Part 160 and areas of OECD GLP will also be covered.

Roles and responsibilities of sponsor in a GLP study as per EPA regulations

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