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.
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.
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.
As we have announced during the EURL Berlin workshop, the first data entry interval on the online database for the collection of method validation data starts today. You can access “ALMANAC – AnaLytical Method vAlidatioN dAta Collection” at https://almanac-methods.de. The collection and evaluation of the data is a task of the EURL laid down in Regulation (EU) 2017/625. With the launch of “ALMANAC” it is now possible for the NRLs to check and amend their method validation data during defined data entry intervals. Outside of these data entry intervals the data can be browsed but not edited. Additionally, it is possible to search the database for laboratories analysing specific matrix-analyte combinations (no display of method parameters). The data from the last method collection initiated by the EURL Berlin is already available in the database at https://almanac-methods.de. All NRLs are now asked to check/update and confirm the entries linked to their laboratory and should add the information of methods covering analytes within the EURL Berlin’s sphere of responsibility which are not yet included in the database. The deadline for this first data entry interval is 15 September, 2021. For a general overview of ALMANAC, please refer to the presentation given during the 2020 EURL workshop (link to FIS-VL).
An account with access to the respective laboratory data has been provided to all eligible laboratories. If there are any problems with the accounts or if you have any question concerning ALMANAC, please contact the EURL at email@example.com. As there is currently no detailed manual available, the EURL Berlin is planning a short training session in the form of a webmeeting for interested users. The meeting is scheduled for 8 July 2021, 10-11.30 a.m. CEST and an official invitation will be sent soon.
Unfortunately, a number of the sample sets shipped on Monday, 7 June, 2021, have not yet been delivered to the participants. We have contacted our logistics provider about the issue and have been informed, that they are dealing with an increased number of shipments. Additionally, they experienced issues with their software, but expressed that they were hopeful, that the delay caused by this should not exceed 24 hours. All participants in the proficiency test STRD0521 who have not yet received their sample set can however be assured that any influences on the analytical results arising from possible instabilities of the solutions will be accounted for in the performance assessment. For general information on the proficiency test, please refer to the following page: STRD0521.
Today, we have once more requested delivery services company to track the whereabouts of the parcels and will inform you of any news right away. Internally, we have discussed to wait until the end of this week and then try to re-ship the samples using a different logistics provider, if possible.
Some of the participants have also expressed concerns about the sample stability. We have conducted a short-term stability study and luckily the majority of the analytes does not show any significant instability, even when stored at room temperature for 28 days. Taking into account last week’s weather, we will also try to accommodate for any additional analyte loss due to the elevated temperatures. As the performance assessment will be conducted using consensus values, participant scores will not be influenced by a loss of analyte due to instability. We have also decided to prolong the deadline for the proficiency test due to the problems with the sample shipment. We have not determined a new date, yet but we will let you know right away.
Thank you for your understanding.
We are pleased to announce that the final report for the interlaboratory study on the analysis of NSAIDs in bovine and equine muscle NSAI1120 is now available. Please retrieve your copy from the FIS-VL. We would be grateful if you would fill out the follow-up questionnaire available here. All participants have received the password via e-mail.
In 2015 the Expert Committee on Residues of Veterinary Medicinal Products indicated that a review of Commission Decision (CD) 2002/657/EC is considered necessary. Subsequently, the EURLs were asked to support DG SANTE in this process. In the following years the EURLs carried out surveys among the NRLs on their view on required changes in this Commission Decision, produced first drafts and discussed the drafts during the annual EURL workshops. Finally, DG SANTE prepared a draft revision (SANTE 11188:2018) which was discussed several times at the Working Group on Residues of Veterinary Medicinal Products and was finally voted on at the SC PAFF in the end of 2020. The document is now published in the Official Journal of the European Union as “Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC” and enters into force in June 2021.
Due to unforeseen circumstances it is necessary to postpone the sample shipment for the proficiency test STRD0521. The new envisaged shipment date will be Monday, 7th June, 2021. In order to accommodate for the upcoming summer break, the time allotted for the analyses will also be extended. The deadline for result submission will be 30th July, 2021.
The workshop will take place on 1 June 2021 in the afternoon and is reserved for those who have participated in proficiency test NSAI1120.
Topics to be covered:
- results of the interlaboratory study
- information from literature
- details of the development and validation of analytical method NSAI_012
- results of additional experiments conducted at the EURL Berlin