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.
Storage and retention of records and materials
Key message: Before collecting data from in vitro methods it is important to assess the format of collection, the complexity involved and requirements for traceability, storage, verification and transmission of data.Key content: The chapter gives insight on what key records and materials to archive and retain. It also details adequate document and record management of processes and the traceability of origin of materials.Guidance for improved practice: Data integrity arrangements must be in place and structured methods and essential process components are described for both paper-based and electronic data to ensure that the collected in vitro method data are attributable, legible, contemporaneous, original and accurate.Recommendations are detailedfor the necessary procedures related to retention, archiving, retrieval, backup and restoration for all target groups involved in the in vitro method lifecycle.
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