Guidance Document on Good In Vitro Method Practices (GIVIMP)

image of Guidance Document on Good In Vitro Method Practices (GIVIMP)

In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context.  To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible.  Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions.  GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.


Executive summary

The rapid expansion in in vitro methods, along with improved understanding of the biological processes involved in toxicological sequelae, have facilitated the development of a variety of predictive in vitro methods. These in vitro methods can be robust alternatives to using animals to identify and characterise chemical safety hazards. In some regulatory sectors, recent changes in regulation now accept, or in some cases, require, in vitro data in lieu of data from animal studies. When the scientific suitability has been demonstrated, the use of in vitro methods can reduce the resources required and increase the efficacy of chemical safety evaluation. In order for these alternatives to be used in regulatory decision making the scientific integrity and quality assurance must be assured.


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