A procedure for assessing a contract testing facility: one sponsor's perspective.

Abstract

The government agencies responsible for Good Laboratory Practices (GLP) place accountability for assuring compliance of studies intended for submission on the sponsor. An initial step toward meeting these legal obligations includes a comprehensive assessment of the candidate testing facility. Literature review has substantiated that the initial evaluation may be best accomplished through both technical and compliance-focused inspections (O'Brien-Pomerleau, 1991; Schroeder, 1989). Combined technical and compliance inspections have also been reported as an effective auditing approach for long-term studies (Hoover and Baldwin, 1984). However, for the purposes of the initial qualifying assessment inspection, personal experiences and published literature indicate that these two equally important evaluations are commonly conducted independently of one another (Scozzie, 1995). A collaborative approach utilized by Dow Corning Corporation in the preliminary assessment of a contract testing facility builds upon those methods just mentioned. Coupling this evaluation with a program of actively monitoring the testing facility's performance in study conduct provides continued assessment and has proven to be beneficial to all stakeholders (sponsor, testing facility, and regulatory agency). Details of the process practiced by this sponsor to assure that studies conducted by a contract testing facility meet GLP requirements are presented.