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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.

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Good Laboratory Practice

Good Laboratory Practice (GLP) was developed in the 1970s in response to fraudulent scientific safety studies that were submitted to receiving authorities in support of applications for the regulatory registration/approval of drugs to the US FDA. Subsequently the principles of GLP were developed by the OECD to ensure data reliability and reconstructability of safety studies. The principles apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing chemical products of various kinds. The principles have been published in 1981 as an annex to the OECD Council Decision on Mutual Acceptance of Data (MAD)See: http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm. The decision states that ‘data generated in the testing of chemicals in an OECD Member Country in accordance with the OECD Test Guidelines (Annex I of this decision) and OECD Principles of Good Laboratory Practice (Annex II of this decision) shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment’. Since 1981 a number of additional guidance, consensus and advisory documents have been published in the OECD Series on Principles of GLPSee: http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm, including an Advisory Document of the OECD Working Group on GLP n° 14 which specifically addresses in vitro Studies (OECD, 2004[1]).

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