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Title (Primary) Framework for the quality assurance of ’omics technologies considering GLP requirements
Author Kauffmann, H.-M.; Kamp, H.; Fuchs, R.; Chorley, B.N.; Deferme, L.; Ebbels, T.; Hackermüller, J.; Perdichizzi, S.; Poole, A.; Sauer, U.G.; Tollefsen, K.E.; Tralau, T.; Yauk, C.; van Ravenzwaay, B.;
Journal Regulatory Toxicology and Pharmacology
Year 2017
Department MOLSYB;
Volume 91
Issue Suppl. 1
Language englisch;
POF III (all) T42; F11;
Supplements https://ars.els-cdn.com/content/image/1-s2.0-S0273230017303094-mmc1.docx
Keywords Good laboratory practice (GLP); Standard operating procedure; Independent quality assurance; Documentation; Data storage; Reproducibility; Raw data definition; Software validation; Quality assurance inspection
UFZ wide themes RU3;
Abstract ‘Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing ‘omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying ‘omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective ‘omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should be validated, and data changes should be traceable or disabled. GLP-compliant quality assurance of ‘omics technologies appears feasible for many GLP requirements. However, challenges include (i) defining, storing, and archiving the raw data; (ii) transparent descriptions of data processing steps; (iii) software validation; and (iv) ensuring complete reproducibility of final results with respect to raw data. Nevertheless, ‘omics studies can be supported by quality measures (e.g., GLP principles) to ensure quality control, reproducibility and traceability of experiments. This enables regulators to use ‘omics data in a fit-for-purpose context, which enhances their applicability for risk assessment.
ID 19425
Persistent UFZ Identifier https://www.ufz.de/index.php?en=20939&ufzPublicationIdentifier=19425
Kauffmann, H.-M., Kamp, H., Fuchs, R., Chorley, B.N., Deferme, L., Ebbels, T., Hackermüller, J., Perdichizzi, S., Poole, A., Sauer, U.G., Tollefsen, K.E., Tralau, T., Yauk, C., van Ravenzwaay, B. (2017):
Framework for the quality assurance of ’omics technologies considering GLP requirements
Regul. Toxicol. Pharmacol. 91 (Suppl. 1), S27 - S35