CORESTA Meeting, Smoke Science/Product Technology, Jeju, 2007, SSPTPOST 12

ISO 17025 accreditation for in vitro toxicology tests on cigarette smoke products

Advanced Technologies Ltd., Cambridge, UK

One of the British American Tobacco Group of companies, Advanced Technologies (Cambridge) Ltd (ATC), performs 'duty of care' in vitro toxicology testing on tobacco products, to examine the potential harmful effects of cigarette smoke on DNA. Genotoxicity tests ( e.g. Ames, In Vitro Micronucleus) identify compounds that have the potential to induce genetic damage. Neutral Red assays identify cytotoxicity. These tests are accepted by OECD1 and NICEATM2 as valid methods for the assessment of the genotoxic and cytotoxic potential of novel compounds. In the wider scientific environment, the majority of these tests are performed as part of the non-clinical safety evaluation testing of novel compounds in accordance with Good Laboratory Practice regulations. Laboratories testing products outside this scope ( e.g. the tobacco industry) cannot apply to be part of the MHRA GLP programme. ATC decided therefore to perform their testing to an international standard, ISO 17025, to confirm the reliability and reproducibility of its results. Generally, ISO 17025 accreditation is undertaken by chemical and physical laboratories who perform tests where the parameters are readily defined and quantitative. Such systems are not applicable to many biological tests ( e.g. in vitro toxicology testing), because the tests are qualitative and imprecise. One of the problems faced is the absence of standards to demonstrate validity of the measurements, therefore the testing needs to be performed under rigorously-controlled conditions. Assessment to the OECD Guidelines and ISO 17025 shows that the laboratory is technically competent, operates robust measurement traceability and internal quality control systems that enable it to accurately analyse materials that are inherently variable. The desire to achieve ISO 17025 accreditation presented several challenges for both ATC and the accrediting body which were successfully overcome, resulting in ATC becoming the first laboratory in Europe to gain ISO 17025 accreditation for in vitro toxicology studies on smoke condensates. 1. Organisation for Economic Co-operation and Development 2. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods