Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs - Scientific guideline

The guideline applies to regulatory testing used for quality control of medicinal products where animals have been traditionally used. It aims to facilitate transfer of quality control methods validated in collaborative trials with a view to implementing the 3Rs – replace, reduce and refine – principles to testing in a product-specific context.

Keywords: 3Rs, collaborative trials, quality control tests, method transfer, validation

Current effective version

Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs

Adopted Reference Number: EMA/CHMP/CVMP/3Rs/94436/2014 Summary:

In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting approaches for validating quality control tests in laboratories for regulatory testing of human and veterinary medicinal products.

Document history - First version (current)

Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs

Adopted Reference Number: EMA/CHMP/CVMP/3Rs/94436/2014 Summary:

In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting approaches for validating quality control tests in laboratories for regulatory testing of human and veterinary medicinal products.

Overview of comments received on 'Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs'

Reference Number: EMA/CHMP/CVMP/3Rs/83712/2017 Summary:

Overview of comments received on 'Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs' (EMA/CHMP/CVMP/3Rs/94436/2014)

Draft guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs

Draft: consultation closed Consultation dates: 29/07/2016 to 31/01/2017 Reference Number: EMA/CHMP/CVMP/JEG-3Rs/94436/2014 Summary:

In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting approaches for validating quality control tests in laboratories for regulatory testing of human and veterinary medicinal products. Collaborative studies between laboratories may be carried out to introduce new 3Rs methods for regulatory purposes where animal tests have been traditionally used. This guidance aims to facilitate transfer of the new methods validated in such trials with a view to implementing 3Rs for testing in a product specific context in laboratories originally involved in the collaborative trial or in new laboratories.

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

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

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.