Guidance Document on Good In Vitro Method Practices (GIVIMP)

This document, Guidance on Good In Vitro Method Practices (GIVIMP), is a series on Testing and assessment No. 286, published by the Organization for Economic Cooperation and Development (OECD). It provides guidelines for the development and implementation of in vitro methods for regulatory use in human safety assessment. The goal is to reduce uncertainties in predictions derived from cell and tissue-based in vitro methods by applying good scientific, technical, and quality practices.

The document covers a broad scope of issues, including the characterization and maintenance of essential characteristics, quality assurance, recording and reporting, safety, education and training, and ethics. It applies to systems based on human and animal cells and tissues. The guidelines recommend that Standard Operating Procedures (SOPs) be written in a clear, easy-to-read format, and that they should be concise, unambiguous, and avoid unnecessary complexity.

The OECD has also published a guidance document on the Validation and International acceptance of New or Updated Test Methods for hazard assessment (No. 34), which promotes a modular approach to validation. This approach organizes the information needed to support the validity of a test method into modules.

In summary, this document provides comprehensive guidelines for the development and implementation of in vitro methods for regulatory use in human safety assessment, with a focus on reducing uncertainties in predictions and promoting international acceptance of test methods.

OECD. Guidance Document on Good In Vitro Method Practices (GIVIMP). OECD Series on Testing and assessment. OECD, 2018. https://doi.org/10.1787/9789264304796-en.