The requirements for characterization of test, control and reference substances are well established under EPA’s 40 CFR Part 160 Good Laboratory Practices. Requirements for the production or synthesis are not addressed in the regulation in the same manner as is the characterization; however, the accuracy and retention of such records to support the preparation of test, control and reference substances are critical to support the reconstruction of the study. Sponsors, Managers, Study Directors and Quality Assurance personnel all play a distinct and important role in the full lifecycle of a test substance. Regulatory requirements can be successfully achieved by having an effective test facility operation that is aligned with EPA’s expectations; this includes establishing well-articulated, management approved standard operating procedures, regularly documented training of GLP personnel, clear organizational structure and responsibilities, and a capable QAU. Using the recent draft OECD GLP Advisory No. 19, “On the Management, Chracterisation and Use of Test Items,” the roles and responsibilities of the Sponsor, Study Director, Management and the Quality Assurance Unit will be discussed as it relates to test substance preparation and characterization through the lifecycle of a pesticide product.

Roles of the Study Director, Management, Sponsor and the Quality Assurance Unit: GLP test control, reference substance preparation and characterization

256th National Meeting (2018)

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