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NIIM1021: Preliminary Report

The preliminary report for the proficiency test STRD0521 is now available on the FIS-VL. The objective of this proficiency test was to allow the participants to assess the performance of their routine methods for the analysis of nitroimidazoles in plasma. Additionally, a milk sample was supplied, which participants were asked to analyse using their routine method for the analysis of milk, or, if no such method was available, their analytical method for plasma. All participants are asked to have a look at their results and communicate any deviations from the results they submitted to the EURL Berlin by 15 December 2021.

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.

BVL: EURL Workshop 2022 – Save the date

We are planning to conduct the 2022 EURL workshop on 05-06 May 2022 at BVL Berlin. If next spring the COVID-19 situation still impacts international travel, we will opt for a web meeting or a hybrid event. We do however hope that we can welcome you in Berlin for a face-to-face meeting. Further details will be published as soon as possible.

STRD0521: Preliminary report

The preliminary report for the proficiency test STRD0521 is now available on the FIS-VL. The objective of this proficiency test was to check the accuracy of the standard solutions participants apply in routine analysis. All participants are asked to have a look at their results and communicate any deviations from the results they submitted to the EURL Berlin by 24 September 2021.

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.

Commenting process for the EURL Guidance document on confirmation method validation initated

The Commission Implementing Regulation 2021/808 which lays down requirements for the performance of methods for the analysis of veterinary drug residues has entered into force on 10 June, 2021. In order to support the implementation of the new CIR, COM has asked the EURLs to provide guidance documents dealing with specific topics which might require supplemental information. The EURLs have drafted several documents, which have been presented during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. The guidance documents are the EURL interpretation of CIR (EU) 2021/808 and are meant as a support for all laboratories, but they are not seen as mandatory to follow and other approaches are possible, if comparable results are achieved. Still, the guidance documents also aim at a harmonised interpretation of CIR (EU) 2021/808 and the EURLs have therefore initiated commenting processes involving the NRLs. Regarding the EURL Guidance document on ongoing quality control the commenting process has come to an end, the document has been finalised and is available here. The comments for the draft EURL Guidance document on method extension have also been reviewed. The first official version is currently in preparation and will soon be published, as well.

We are pleased to announce that a draft version of the EURL Guidance document on confirmation method validation has been compiled and submitted to the NRLs for their comments and suggestions. All NRLs are asked to provide their feedback to the EURLs by 15 September, 2021. As a final step all comments will then be reviewed and the draft will be amended. It is expected that the final version of this document will be published towards the end of 2021.

STRD0521: New deadline

The replacement sample sets for the proficiency test STRD0521 have been picked up by the logistics provider at BVL yesterday. The parcels are currently en route and are scheduled to arrive at their destination today or tomorrow. All participants expecting a replacement shipment are asked to confirm the sample receipt immediately using the form available here. The password has been provided by e-mail.

Considering the delay caused by the loss of the shipments by the logistics provider which now shifts the time alotted for the sample analysis into the summer holiday season, the EURL Berlin has decided to adjust the deadline for result submission. The new deadline will be 06 September, 2021.