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.


Roles and responsibilities

Key message: The in vitro method life cycle from development to their use for safety assessment purposes has a variety of key actors and the guidance identifies clearly their responsibilities, both individually and collectively.Key content: Describes all target groups involved in the process e.g., in vitro method developers, test system (cells, tissues) providers, validation bodies, inter-governmental organisations for cooperation, suppliers of equipment, materials and reagents, in vitro method users (e.g., testing laboratories, large industries and small to medium enterprises), sponsors, receiving authorities and GLP monitoring authorities.Guidance for improved practice: Besides the elements necessary for good scientific work in discovery, additional requirements, such as documentation, ownership, identity and genetic make-up, related to the in vitro method and the test system, are key for their in vitro method acceptance at regulatory level.Recommendations are given for several of the target groups on how to put into practice their responsibilities for facilitating the development and implementation of in vitro methods for regulatory use.


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