QAU verification: Ricerca's approach to EPA requirements for specimen disposition

The U.S. Environmental Protection Agency (EPA) Federal Insecticide. Fungicide and Rodenticide Act and Toxic Substance Control Act Standards issued in 1989 presented a new task for the Quality Assurance Unit (QAU). Sections .190 and .195 of these Good Laboratory Practice (GLP) Standards require "quality assurance verification" prior to the disposal of certain specimens. These include "specimens from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids." QAU involvement in the specimen disposition process was a new concept. Other GLP Standards required specimen retention only as long as the quality of the preparation afforded evaluation: the QAU was not included in the procedure. The QAU verification step was included by the EPA to ensure that disposal of the prescribed specimens would not compromise the integrity of the study. A procedure to address verification of specimen disposition as required by the EPA GLP Standards has been implemented by Ricerca's QAU. This presentation provides a description of this approach to QAU verification.