OECD Series on OECD Series on Testing and Assessment Testing and Guidance Document on Good Assessment In Vitro Method Practices (GIVIMP) Guidance Document on Good In Vitro Method Practices (GIVIMP) No. 286 OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) No. 286 This document was approved by the Working Group of the National Coordinators of the Test Guidelines Programme in April 2018, and is published under the responsibility of the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. This document, as well as any data and any map included herein, are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area. Please cite this publication as: OECD (2018), Guidance Document on Good In Vitro Method Practices (GIVIMP), OECD Series on Testing and Assessment, No. 286, OECD Publishing, Paris. https://doi.org/10.1787/9789264304796-en ISBN 978-92-64-30479-6 (pdf) Series: OECD Series on Testing and Assessment ISSN 2077-7876 (online) The statistical data for Israel are supplied by and under the responsibility of the relevant Israeli authorities. The use of such data by the OECD is without prejudice to the status of the Golan Heights, East Jerusalem and Israeli settlements in the West Bank under the terms of international law. 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ABOUT THE OECD │ 3 About the OECD The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organisation in which representatives of 36 industrialised countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonise policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD’s work is carried out by more than 200 specialised committees and working groups composed of member country delegates. Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD’s workshops and other meetings. Committees and working groups are served by the OECD Secretariat, located in Paris, France, which is organised into directorates and divisions. The Environment, Health and Safety Division publishes free-of-charge documents in twelve different series: Testing and Assessment; Good Laboratory Practice and Compliance Monitoring; Pesticides; Biocides; Risk Management; Harmonisation of Regulatory Oversight in Biotechnology; Safety of Novel Foods and Feeds; Chemical Accidents; Pollutant Release and Transfer Registers; Emission Scenario Documents; Safety of Manufactured Nanomaterials; and Adverse Outcome Pathways. More information about the Environment, Health and Safety Programme and EHS publications is available on the OECD’s World Wide Web site (www.oecd.org/chemicalsafety/). This publication was developed in the IOMC context. The contents do not necessarily reflect the views or stated policies of individual IOMC Participating Organizations. The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was established in 1995 following recommendations made by the 1992 UN Conference on Environment and Development to strengthen co-operation and increase international co-ordination in the field of chemical safety. The Participating Organisations are FAO, ILO, UNDP, UNEP, UNIDO, UNITAR, WHO, World Bank and OECD. The purpose of the IOMC is to promote co- ordination of the policies and activities pursued by the Participating Organisations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) © OECD 2018 FOREWORD │ 5 Foreword A guidance document on Good In Vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment was identified as a high priority requirement by the OECD. The aim of this guidance document is to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by applying all necessary good scientific, technical and quality practices from in vitro method development to in vitro method implementation for regulatory use. This guidance document also applies to in vitro methods already accepted by the OECD. Development of GIVIMP began in 2013 when the OECD Working Group on Good Laboratory Practice (WG GLP) and the Working Group of the National Coordinators of the Test Guidelines Programme (WNT) agreed that there was merit in having guidance for OECD countries on these important issues. The draft guidance was coordinated by the validation body European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and was accepted on the work plan of the OECD test guideline programme in April 2015 as a joint activity between the WG GLP and the WNT. The guidance is targeted primarily at users that implement in vitro methods, but also provides guidance for in vitro method developers. The document satisfies the following objectives; 1. A detailed update on good practices for state-of-the-art in vitro methods applied to regulatory human safety assessment of a variety of compounds. 2. Guidance to users and implementers of in vitro methods to help to ensure that Standard Operating Procedures (SOPs) of such methods are well-designed, robust, well-defined and described and can be carried out in a GLP environment, which is essential for use in a regulatory context. 3. Description of the key aspects that may impact the reliability and relevance of the in vitro data for quantitative human safety assessment purposes. 4. Description of the importance of reporting criteria, applying good experimental design, establishing acceptance criteria, and performance standards based on scientific evidence from the generated in vitro datasets. The development and revision of GIVIMP has occurred with input from a large group of experts, including experts from both the WG GLP and the WNT. Additionally, an OECD GIVIMP expert group (established specifically for GIVIMP) provided input through teleconferences, a face-to-face meeting and two rounds of written comments. In January 2017 the first round of comments of the OECD WG GLP and nominated experts of the OECD WNT were forwarded to EURL ECVAM who incorporated these comments, where applicable, and prepared an updated version. The OECD GIVIMP expert group addressed specific outstanding issues on the 23 and 24 March 2017 (Annex D OECD GIVIMP meeting 23-24 March, 2017) and agreed on content, structure, and wording of the GIVIMP so as to provide the OECD with an updated version ready to GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) © OECD 2018 6 │ FOREWORD enter the second OECD commenting round. After this round, during summer 2017, EURL ECVAM prepared the final GIVIMP version, which was submitted to OECD for adoption. GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) © OECD 2018 TABLE OF CONTENTS │ 7 Table of contents About the OECD ................................................................................................................................... 3 Foreword ................................................................................................................................................ 5 Introduction ......................................................................................................................................... 13 Executive summary ............................................................................................................................. 17 Scope ..................................................................................................................................................... 19 References .......................................................................................................................................... 21 Chapter 1. Roles and responsibilities ................................................................................................. 23 1.1. In vitro method developers ......................................................................................................... 24 1.2. Test system providers ................................................................................................................. 25 1.3. Validation bodies ........................................................................................................................ 28 1.4. Inter-governmental organisation for cooperation ......................................................................