OECD Publishes Second Edition of Good In Vitro Method Practices (GIVIMP) to Standardize Non-Animal Testing
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The OECD has published the Second Edition of its Guidance Document on Good In Vitro Method Practices (GIVIMP), No. 421 in the Series on Testing and Assessment. This document is a foundational resource aimed at promoting the rigor and reproducibility of new approach methodologies (NAMs) and in vitro methods used for human safety assessment.
The purpose of GIVIMP is to reduce uncertainties in cell- and tissue-based in vitro method-derived chemical safety predictions by applying necessary good scientific, technical, and quality practices. The guidance provides a comprehensive quality framework for the entire life cycle of an in vitro method, detailing best practices across ten critical chapters:
Roles and Responsibilities (for developers, users, and regulators).
Quality Considerations (QA/QC, risk assessment, staff training).
Facilities and Apparatus (design, safety, calibration).
Test Systems (cell/tissue sourcing, maintenance, contamination screening).
Method Performance (acceptance criteria, experimental design).
Reporting of Results (for regulatory purposes and Mutual Acceptance of Data - MAD).
Storage and Retention of Records (data integrity and archiving).
The second edition includes additional content, notably on ethical issues associated with the use of human serum.
Policy Relevance
GIVIMP is critical for accelerating the global regulatory acceptance of non-animal testing alternatives, a key goal of chemical safety regulation. For India, this document serves as a critical operational roadmap to bridge the gap between ethical commitment and credible regulatory science, impacting trade, quality systems, and R&D capacity.
Aligning with India’s 3Rs Mandate: India’s animal experimentation oversight framework operationalises and promotes the 3Rs (Replacement, Reduction, Refinement) through its guidelines and SOPs issued under the Prevention of Cruelty to Animals Act. GIVIMP provides detailed technical and documentation benchmarks that Indian regulators such as CCSEA, CDSCO, and FSSAI can use to reliably implement ‘Replacement’ by defining when high-quality in vitro data are acceptable in lieu of animal tests.
Trade and Regulatory Credibility: Adopting GIVIMP-consistent practices enhances the export competitiveness of Indian companies (chemicals, pharmaceuticals, personal care) seeking market access in the EU and other OECD regions that increasingly demand non-animal safety data. Convergence on these practices would make Indian labs’ in vitro data more readily usable in the OECD’s Mutual Acceptance of Data (MAD) system.
Quality System Upgrade: India’s GLP-compliant labs and standard-setting bodies (BIS) can incorporate GIVIMP’s detailed chapters on Quality Assurance/Quality Control (QA/QC), data integrity, and archiving as annexes to their existing frameworks, thereby strengthening regulatory confidence in domestically-generated alternative data.
Follow the full news here: Guidance Document on Good In Vitro Method Practices