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QUALITY ASSURANCE FOR IN VITRO ALTERNATIVE TEST METHODS: QUALITY CONTROL ISSUES IN TEST KIT PRODUCTION.

Rispin1, A., Harbell2, J.W., Klausner3, M., Jordan4, F.T., Coecke5, S., Gupta6, K., Stitzel7, K. 1US Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, DC, USA; 2Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA; 3MatTek Corporation, Ashland, MA, USA; 4Charles River Endosafe Corporation, Wilmington, MA, USA; 5European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy; 6US Consumer Product Safety Commission, Bethesda, MD, USA; 7Consultant, West Chester, OH, USA.
Abstract

In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the data from these methods also need to be reassured that the proprietary materials and the test kits will provide consistent, good quality data over time, not just during the validation process. This paper presents an overview of the methods currently used by representatives of kit manufacturers and contract testing laboratories to ensure that the results from methods that utilize test kits are reproducible over time and across different types of test materials. This information will be valuable as a basis for future discussion on the need for formalized oversight of the quality of these materials.

Keywords

Alternative test methods, Animal test replacement, ECVAM, ET-50, EpiDerm, EpiOcular, FDA, GCCP, GLP , GMP, Good cell culture practice (GCCP), ICCVAM, In vitro, Intra-lot reproducibility, Limulus assay, MTT, MTT ET-50 assay, OECD, Pyrogen testing, Quality assurance, Reproducible , Skin constructs, Test kits, Validation

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