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International guidance on good practice for the development and application of in vitro methods

Good In Vitro Method Practices (GIVIMP)
©EU, 2018
Sep 17 2018

The Organisation for Economic Cooperation and Development (OECD) has published guidance on Good In Vitro Method Practices (GIVIMP) to ensure the reliability and integrity of in vitro data used for the safety assessment of chemicals. JRC scientists of the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) contributed to the guidance, within the context of a project of the OECD Test Guidelines Programme.

The guidance document is intended to support method developers and end-users working in academic, industry or government laboratories across all 36 OECD member countries and beyond.

GIVIMP addresses key elements of good in vitro practice including:

  • clear definition of roles and responsibilities,
  • procedures for storing and handling cells and tissues,
  • ways to prepare test items and avoid cross-contamination,
  • defining and describing standard operating procedures and how to properly report results.

Modern in vitro methods are typically based on human cells or engineered tissues and are designed to identify potentially harmful effects of chemicals used in a variety of contexts including consumer goods, industrial processes and plant protection products. They are fast becoming key tools for a new way of doing toxicology without resorting to animal testing. Test data derived from in vitro methods are increasingly being used in combination with other information within Integrated Approaches to Testing and Assessment (IATA) to support safety decisions. However, good practices are essential to ensure that in vitro data can be trusted by industry end-users and regulatory authorities for the protection of workers, consumers and the environment.

Moreover, in vitro methods that undergo validation often require improvements in their design and implementation before they can be evaluated regarding their reliability and relevance for a particular regulatory purpose. Applying GIVIMP during the development of in vitro methods will help improve the quality of submitted methods and ultimately the efficiency of validation studies.

The development of GIVIMP was coordinated by the JRC’s EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) within the context of a project of the OECD Test Guidelines Programme.

A large number of international experts, including members of a dedicated OECD expert group and the European Union Network of Validation Laboratories (EU-NETVAL), contributed to the state-of-the-art knowledge gathered within the guidance document. GIVIMP also benefitted from a number of written commenting rounds and two expert meetings before its final endorsement by the OECD's working party for national coordinators of the test guidelines programme in April 2018.

Read more in: OECD (2018). Guidance Document on Good In Vitro Method Practices (GIVIMP) – OECD Series on Testing and Assessment No. 286. ENV/JM/MONO(2018)19. OECD Publishing, Paris.

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