Transferring quality control methods validated in collaborative trials to a product/laboratory specific context - Scientific guideline

This document proposes the development of guidance on how published data from the collaborative study can be used to support laboratory and product specific validation of 3Rs (replacement, reduction, refinement) methods in order to facilitate implementation of such methods for product specific testing. It would also provide guidance on how these data can be used to support in-house validation for other laboratories not involved in the collaborative work.

Keywords: Quality control, replacement, reduction, refinement, 3Rs, transfer

Current effective version

Concept paper on transferring quality control methods validated in collaborative trials to a product / laboratory specific context

Draft: consultation closedConsultation dates: 18/07/2014 to 31/10/2014Reference Number: CHMP/CVMP/JEG-3Rs/94304/2014Summary:

This concept paper proposes the development of guidance on how data can be used to support laboratory- and product-specific validation of 3Rs (reduction, replacement and refinement) methods in order to facilitate implementation of methods for product-specific testing. The paper would also provide guidance on how published data from collaborative studies can be used to support in-house validation for other laboratories not involved in the collaborative work.