Abstract
Reliable data are essential for the assessment and evaluation of the toxicological characteristics of chemical substances and of safe exposure levels for man and the environment. Data reliability is closely linked with the exclusion or minimization of errors and mistakes in the generation of data. These objectives can be reached by the implementation of appropriate Quality Assurance (QA) systems as an important part of the Quality Management (QM). The major characteristics and differences of the more important quality assurance systems are presented in this chapter.
This is a preview of subscription content, log in via an institution.
References
Beronius A, Molander L, Zilliacus J, Rudén C, Hanberg A (2018) Testing and refining the Science in Risk Assessment and Policy (SciRAP) web-based platform for evaluating the reliability and relevance of in vivo toxicity studies. J Appl Toxicol 1–11. https://doi.org/10.1002/jat.3648
Briner W, Kirwan J (2017) Experimental toxicology: issues of statistics, experimental design, and replication. Neurotoxicology 58:137–142
DFG (Deutsche Forschungsgemeinschaft) (2019) Guidelines for safeguarding good research practice. https://www.dfg.de/download/pdf/foerderung/rechtliche_rahmenbedingungen/gute_wissenschaftliche_praxis/kodex_gwp_en.pdf. Accessed 26 Jan 2020
EFSA (European Food Safety Authority) (2020) http://www.efsa.europa.eu/. Accessed 2 July 2020
EMA (European Medicines Agency) (2020) Good clinical practice. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice. Accessed 27 Jan 2020
European Commission (2020) Good laboratory practice. https://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_en. Accessed 26 Jan 2020
ICH (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use) (1996) ICH harmonised Tripartite Guideline, Guideline for Good Clinical Practice, E6(R1), dated 10 June 1996
ICH (International Council on Harmonisation of technical requirements for registration of pharmaceuticals for human use) (2016) Integrated addendum to ICHE6(R1): guideline for good clinical practice E6(R2) current step 4 version dated 9 November 2016. www.ich.org/products/guidelines/efficacy. Accessed 27 Jan 2020
Ishikawa K (1968) Guide to quality control. JUSE, Tokyo
Klimisch HJ, Andrae M, Tillmann U (1997) A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25:1–5
Miller GW (2014) Improving reproducibility in toxicology. Toxicol Sci 139(1):1–3
OECD (Organisation for Economic Co-operation and Development) (1981) Decision of the council concerning the mutual acceptance of data in the assesment of chemicals [C(81)30(Final)] (Adopted by the Council at its 535th Meeting on 12th May, 1981)
OECD (Organisation for Economic Co-operation and Development) (2020) Good laboratory practice (GLP). http://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm. Accessed 27 Jan 2020
U.S. EPA (United States Environmental Protection Agency) FIFRA (1983) Good laboratory practice standards: final rule. US Code of Federal Regulations, Chapter 40, Part 160. First published in Federal Register, November 1983. Current version: available at www.ecfr.gov or http://www.epa.gov/compliance/monitoring/programs/fifra/glp.html. Accessed 26 Jan 2020
U.S. FDA (U.S. Food and Drug Administration) (1978) Nonclinical laboratory studies – good laboratory practice regulations. Fed Regist 43(247):59986–60025
U.S. FDA (U.S. Food and Drug Administration) (2020) Comparison chart of FDA and EPA good laboratory practice (GLP) regulations and the OECD principles of GLP. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/comparison-chart-fda-and-epa-good-laboratory-practice-glp-regulations-and-oecd-principles-glp. Accessed 27 Jan 2020
Recommended Reading
EEC (1999) Commission Directive 1999/11/EU of 8 March 1999 adopting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC. Official Journal of the European Communities, 23 March 1999, No L 77, pp 8–21
OECD (1995) Council Decision amending the Annexes to the Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice. C(95)8 of March 1995. With Annex I (Revised guides for compliance monitoring procedures for GLP) and Annex II (Revised guidance for the conduct of laboratory inspections and study audits)
Seiler JP (2005) Good laboratory practice, 2nd edn. Springer, Berlin/Heidelberg
Weinberg S (2003) Good laboratory practice, 3rd edn. Marcel Dekker, New York/Basel
WHO (World Health Organization) (2009) Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development, 2nd edn. World Health Organization, Geneva
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2020 Springer-Verlag GmbH Germany, part of Springer Nature
About this entry
Cite this entry
Wollin, KM., Harston, S., Lilienblum, W. (2020). Quality Assurance in Toxicology. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-36206-4_28-2
Download citation
DOI: https://doi.org/10.1007/978-3-642-36206-4_28-2
Received:
Accepted:
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-36206-4
Online ISBN: 978-3-642-36206-4
eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences