CEN ISO/TS 23758:2021

Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021)

This document describes general workflows and protocols for the validation and the verification of qualitative screening tests for the detection of residues of veterinary drugs in liquid milk (raw, pasteurized, UHT and reconstituted milk powders and whey protein extracts) including biological methods. This guideline does not cover the validation of residue analysis by HPLC, UHPLC or LC-MS/MS.
This document is intended to be useful for manufacturers of screening test kits, laboratories validating screening methods or tests, competent authorities and dairies or end users of reagents or tests for the detection of veterinary drug residues in milk products. This document facilitates and improves the validation and verification of screening methods. The goals of this document are a harmonization in validation of methods or test kits in order for all stakeholders to have full trust in the result of residue screening and to limit the overlap and multiplication of validation work in different laboratories by sharing the validation results generated by an independent laboratory. Furthermore, a harmonized validation and verification procedure allows for comparison of the performance of different screening methods.
This document does not imply that all end users are bound to perform all verification work proposed.
The verification of the correct use of reagents/kits for the detection of antimicrobials is not part of the scope of this document.

Leitlinie für die Validierung qualitativer Screening-Verfahren zur Detektion von Tierarzneimittelrückständen in Milch und Milcherzeugnissen (ISO/TS 23758:2021)

Dieses Dokument beschreibt allgemeine Arbeitsabläufe und Arbeitsvorschriften für die Validierung und Verifizierung von qualitativen Screening-Tests zum Nachweis von Tierarzneimittelrückständen in Flüssigmilch (roh, pasteurisiert, UHT sowie rekonstituierte Milchpulver und Molkeneiweißextrakte), einschließlich biologischer Verfahren. Diese Leitlinie umfasst nicht die Validierung der Rückstandsanalyse durch HPLC, UHPLC oder LC-MS/MS.
Dieses Dokument soll für Hersteller von Screening-Testkits, Labore, die Screening-Verfahren oder  Tests validieren, zuständige Behörden und Molkereien oder Endanwender von Reagenzien oder Tests zum Nachweis von Tierarzneimittelrückständen in Milcherzeugnissen nützlich sein. Dieses Dokument erleichtert und verbessert die Validierung und Verifizierung von Screening-Verfahren. Die Ziele dieses Dokuments sind eine Harmonisierung der Validierung von Verfahren oder Testkits, damit alle Beteiligten volles Vertrauen in das Ergebnis des Rückstand-Screenings haben, und die Überschneidung und Vervielfachung der Validierungsarbeit in verschiedenen Laboren durch das zur Verfügung stellen der von einem unabhängigen Labor erzielten Validierungsergebnisse zu begrenzen. Darüber hinaus ermöglicht eine harmonisierte Validierungs  und Verifizierungsverfahrensweise einen Vergleich der Leistungsfähigkeit verschiedener Screening-Verfahren.
Dieses Dokument impliziert nicht, dass alle Endanwender verpflichtet sind, alle vorgeschlagenen Verifizierungsarbeiten durchzuführen.
Die Verifizierung der korrekten Anwendung von Reagenzien/Kits zum Nachweis antimikrobiell wirksamer Substanzen ist nicht Teil des Anwendungsbereichs dieses Dokuments.

Lignes directrices pour la validation des méthodes qualitatives de dépistage des résidus de médicaments vétérinaires dans le lait et les produits laitiers (ISO/TS 23758:2021)

Le présent document spécifie des processus et protocoles généraux pour la validation et la vérification des essais qualitatifs de dépistage des résidus de médicaments vétérinaires dans le lait à l’état liquide (lait cru, lait pasteurisé, lait UHT et lait en poudre reconstitué et concentrés de protéine de lactosérum) incluant des méthodes biologiques. Ces lignes directrices ne couvrent pas la validation de l’analyse des résidus par CLHP, CLUHP ou CL-SM/SM.
Le présent document vise à apporter une aide aux fabricants de kits d’essai de dépistage, aux laboratoires validant des méthodes de dépistage ou des essais, aux autorités compétentes et aux laiteries ou aux utilisateurs finaux de réactifs ou d’essais dans le cadre du dépistage de résidus de médicaments vétérinaires dans les produits laitiers. Le présent document facilite et améliore la validation et la vérification de méthodes de dépistage. Le présent document vise d’une part à harmoniser la validation des méthodes ou des kits d’essai afin que l’ensemble des parties prenantes aient une totale confiance dans le résultat d’un dépistage de résidus, et d’autre part à limiter le chevauchement et la multiplication des activités de validation menées par différents laboratoires en partageant les résultats de validation produits par un laboratoire indépendant. Une procédure harmonisée de validation et de vérification permet en outre de comparer les performances de différentes méthodes de dépistage.
Le présent document ne sous-entend pas que tous les utilisateurs finaux soient liés pour réaliser l’ensemble des activités de vérification proposées.
La vérification de l’usage correct des réactifs/kits de dépistage des antimicrobiens n’est pas couverte par le domaine d’application du présent document.

Smernice za validacijo kvalitativnih presejalnih metod za detekcijo ostankov veterinarskih zdravil v mleku in mlečnih proizvodih (ISO/TS 23758:2021)

General Information

• Status: Published
• Publication Date: 24-Aug-2021
• ICS: 67.100.01 - Milk and milk products in general
• Technical Committee: CEN/TC 302 - Milk and milk products - Methods of sampling and analysis
• Drafting Committee: CEN/TC 302 - Milk and milk products - Methods of sampling and analysis
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 25-Aug-2021
• Completion Date: 25-Aug-2021
• Ref Project: SIST-TS CEN ISO/TS 23758:2021 - Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2021
Smernice za validacijo kvalitativnih presejalnih metod za detekcijo ostankov
veterinarskih zdravil v mleku in mlečnih proizvodih (ISO/TS 23758:2021)
Guidelines for the validation of qualitative screening methods for the detection of
residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021)
Leitlinie für die Validierung qualitativer Screening-Methoden zur Detektion von
Tierarzneimittelrückständen in Milch und Milcherzeugnissen (ISO/TS 23758:2021)
Lignes directrices pour la validation des méthodes qualitatives de dépistage des résidus
de médicaments vétérinaires dans le lait et les produits laitiers (ISO/TS 23758:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 23758:2021
ICS:
11.220 Veterinarstvo Veterinary medicine
67.100.01 Mleko in mlečni proizvodi na Milk and milk products in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 23758
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
August 2021
TECHNISCHE SPEZIFIKATION
ICS 67.100.01
English Version
Guidelines for the validation of qualitative screening
methods for the detection of residues of veterinary drugs
in milk and milk products (ISO/TS 23758:2021)
Lignes directrices pour la validation des méthodes Leitlinie für die Validierung qualitativer Screening-
qualitatives de dépistage des résidus de médicaments Methoden zur Detektion von
vétérinaires dans le lait et les produits laitiers (ISO/TS Tierarzneimittelrückständen in Milch und
23758:2021) Milcherzeugnissen (ISO/TS 23758:2021)
This Technical Specification (CEN/TS) was approved by CEN on 29 July 2021 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 23758:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 23758:2021) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 302 “Milk and milk products - Methods of
sampling and analysis” the secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 23758:2021 has been approved by CEN as CEN ISO/TS 23758:2021 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 23758
IDF/RM 251
First edition
2021-08
Guidelines for the validation of
qualitative screening methods for the
detection of residues of veterinary
drugs in milk and milk products
Lignes directrices pour la validation des méthodes qualitatives de
dépistage des résidus de médicaments vétérinaires dans le lait et les
produits laitiers
Reference numbers
ISO/TS 23758:2021(E)
IDF /RM 251:2021(E)
©
ISO and IDF 2021
ISO/TS 23758:2021(E)
IDF /RM 251:2021(E)
© ISO and IDF 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office International Dairy Federation
CP 401 • Ch. de Blandonnet 8 Silver Building • Bd Auguste Reyers 70/B
CH-1214 Vernier, Geneva B-1030 Brussels
Phone: [phone] Phone: [phone]
Fax: [phone]
Email: [e-mail] Email: [e-mail]
Website: www.iso.org Website: www.fil-idf.org
Published in Switzerland
ii © ISO and IDF 2021 – All rights reserved

ISO/TS 23758:2021(E)
IDF /RM 251:2021(E)
Contents Page
Forewords .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 General requirements for the test/kit . 5
6 Reagents . 5
6.1 Standard blank matrix . 5
6.2 Antibiotics . 6
6.3 Standard stock solution . 6
6.4 Working stock solutions . 6
6.5 Spiked sample . 6
7 Apparatus . 7
8 Sample Preparation. 7
8.1 Stock solution preparation . 7
8.2 Working stock solution preparation . 8
8.3 Blank matrix sample selection . 8
8.4 Spiked sample creation . 8
9 Procedure. 8
9.1 Validation . 8
9.1.1 General. 8
9.1.2 Detection capability (CCβ). 9
9.1.3 Test selectivity/specificity .13
9.1.4 Robustness testing .14
9.1.5 Reader and test repeatability .18
9.1.6 Participation in a(n) (inter)national ring trial .20
9.2 V erification testing of a transferred screening method .20
9.2.1 General.20
9.2.2 Detection capability .21
9.2.3 Test selectivity/specificity .21
9.2.4 Robustness testing .21
9.2.5 Reader and test repeatability .21
9.2.6 Participation in a(n) (inter)national ring trial .23
Annex A (informative) European legislation on veterinary drugs in cow milk .24
Annex B (informative) USA legislation on animal drug residues in milk .28
Annex C (informative) List of problematic compounds in the preparation of stock solutions .29
Annex D (informative) Summary of the stability of antibiotics in solution and in matrix .30
Bibliography .33
ISO/TS 23758:2021(E)
IDF /RM 251:2021(E)
Forewords
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which
a technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part
in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different
...