Internationally harmonized processes for test method evaluation, validation and regulatory acceptance: The role of OECD guidance document 34

Historically, test method evaluation, validation and review processes and criteria have been generally region-specific, often resulting in duplicative efforts and, at times, incongruent conclusions regarding the quality and utility of a test method. In an attempt to standardize such review and evaluation processes so as to render them globally consistent, experts in these arenas from such international validation bodies as ICCVAM, NICEATM, ECVAM, ESAC, ZEBET, and JaCVAM have been working toward the generation of international guidance and mutually acceptable validation principles. From this effort, the OECD Guidance Document (GD) 34 (Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment) evolved [http://appli1.oecd.org/olis/2005doc.nsf/linkto/env-jmmono(2005)14]. Guidelines and processes actively in use by ICCVAM and ECVAM contributed greatly to arriving at the final GD 34. As such, GD 34 now provides guidance on key factors such as approaches to validation, the design and conduct of validation studies, independent evaluation (peer review) of a validation study, international regulatory acceptance of validated tests, and documentation supporting a validation study. This important document has provided the basis for an internationally agreed-upon and consistent approach for the open and transparent assessment of new and alternative test methods with potential regulatory applicability. Conforming to the GD 34 principles by the validation body collective and by OECD itself is a requisite to the expediency, efficiency and credibility of validation efforts irrespective of where or by whom they may be conducted.