Our Environmental and Metabolic Fate division conducts a variety of different studies that can require between 1 month and 3 years to complete. Our master schedule for this division can contain as many as 50-75 of these studies. Since the Good Laboratory Practices (GLP) regulations require in-study inspections at intervals adequate to assure study integrity and our quality assurance unit (QAU) standard operating procedure (SOP) requires us to monitor studies that last longer than 3 months at least once a quarter, in-study inspection scheduling can be challenging. In order to keep up with the work load described we have developed a method using a spreadsheet program, Excel, to facilitate in-study inspection scheduling through periodic reporting of all QAU inspection activity to the study director. This report makes the scheduling of critical phase and quarterly inspections a cooperative effort between the study director and QAU auditor. The details of the development and utilization of Excel for these "in-study inspection tracking reports" are presented.

Since the inception of the Food and Drug Administration's Good Laboratory Practice Regulations and Environmental Protection Agency's Good Laboratory Practice Standards, many "questions and answer" documents have been produced. Our purpose in this presentation is to pull together some of these reference documents and provide a cross-reference index to sort through the many topics and questions. The combined reference resource and index provide the quality assurance professional a useful Good Laboratory Practice information tool.

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.