Tag Archives: Guidance documents

EURL Guidance Document on Confirmation Method Validation published

In order to support the harmonised interpretation and the implementation of the Commission Implementing Regulation 2021/808 laying down requirements for the performance of methods for the analysis of veterinary drug residues, COM has asked the EURLs to provide guidance documents dealing with specific aspects which might require supplemental information. Now, the EURL Guidance Document on Confirmation Method Validation has been finalised and is available as of today.

The document provides suggestions for the validation of confirmation methods based on the conventional and the alternative validation approach. Furthermore, the document’s annex offers an overview of the major differences in requirements laid down in Commission Decision 2002/657/EC and Commission Implementing Regulation (EU) 2021/808.

The drafts of the guidance document on confirmation method validation were presented and discussed during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. Additionally, all NRLs had the opportunity to provide comments in order to increase the document’s practicality.

Although the guidance document represents the EURLs’ interpretation of CIR (EU) 2021/808 and is meant as a support for all laboratories, it is not seen as mandatory to follow. Other approaches are possible, if they provide plausible and comparable results. However, we sincerely hope that you will find the document useful, especially in conjunction with the EURL Guidance document on method extension, also available from the EURL website.

Guidance document on method extension published

In order to support the harmonised interpretation and the implementation of the Commission Implementing Regulation 2021/808 laying down requirements for the performance of methods for the analysis of veterinary drug residues, COM has asked the EURLs to provide guidance documents dealing with specific aspects which might require supplemental information. Now, the EURL guidance document on method extension has been finalised and is available as of today.

The document provides some general reflections on the extension of analytical methods to additional analytes, matrices or the adaption of the validated concentration range. Furthermore, model approaches and practical examples for the extension of methods previously validated applying the conventional and the alternative validation approach are introduced.

The drafts of the guidance document were presented and discussed during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. Additionally, all NRLs had the opportunity to provide comments and suggestions in order to increase the document’s practicality. Although the guidance document represents the EURLs’ interpretation of CIR (EU) 2021/808 and is meant as a support for all laboratories, it is not seen as mandatory to follow. Other approaches are possible, if they provide plausible and comparable results.