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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.

English

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Quality considerations

Key message: To realise fully the potential of in vitro methods and allowing them to become a key tool for a new way of doing toxicology, they need to be developed and applied in a way that scientific integrity and quality is assured.Key content: Discusses quality assurance versus quality control, quality risk-based assessment and quality control requirements for development and implementation of in vitro methods, the types of documentation needed and quality considerations regarding the integrity of the data.Guidance for improved practice: Control charts can be used as a powerful and simple statistical tool to help routinely monitor the quality of any quantitative process and to determine if the process is in a state of control.Recommendations for basic quality risk assessment questions and applicability of integrity checks on cell and tissue cultures are described.

English

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