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.
Facilities
Key message: In vitro cell and tissue culture facilities should be fit for purpose and a detailed understanding of the work flow for the in vitro method related processes is essential. The separation of specific laboratory functions and elements that can adversely impact in vitro method work need to be understood.Key content: Elaborates safety, safety risk assessment and management including descriptions of Risk Groups and Biosafety Level requirements, proper facility design to ensure integrity of the cell and tissue cultures, the in vitro method itself and the resulting data.Guidance for improved practice: This chapter describes guidance on level of separation to avoid cross-contamination and quarantine measures for new test systems. A flow diagram indicating movement of staff, materials and reagents, test systems and test and reference items, and waste collections shows what processes need to be separated.Recommendations for classification of infective microorganisms, laminar flow biological safety cabinets and biosafety levels, are given.
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