PD 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

Standard Number: PD CEN ISO/TS 23758:2021

Pages: 44

Released: 2021-09-07

ISBN: 978 0 539 15334 7

Status: Standard

Overview

The PD CEN ISO/TS 23758:2021 standard provides comprehensive guidelines for the validation of qualitative screening methods aimed at detecting residues of veterinary drugs in milk and milk products. This essential document is a must-have for professionals in the dairy industry, regulatory bodies, and laboratories involved in food safety and quality control.

Why This Standard is Essential

Ensuring the safety and quality of milk and milk products is of paramount importance. Veterinary drugs, if present in milk, can pose significant health risks to consumers. The PD CEN ISO/TS 23758:2021 standard offers a robust framework for validating qualitative screening methods, ensuring that these methods are reliable, accurate, and effective in detecting residues of veterinary drugs.

Key Features

• Comprehensive Guidelines: Detailed instructions on the validation process, ensuring that screening methods meet the highest standards of accuracy and reliability.
• Industry Relevance: Specifically tailored for the dairy industry, addressing the unique challenges and requirements of detecting veterinary drug residues in milk and milk products.
• Regulatory Compliance: Helps laboratories and dairy producers comply with national and international regulations, safeguarding public health and maintaining consumer trust.
• Expert Insights: Developed by leading experts in the field, providing authoritative guidance and best practices.

Who Should Use This Standard?

The PD CEN ISO/TS 23758:2021 standard is an invaluable resource for a wide range of stakeholders, including:

• Dairy Producers: Ensuring the safety and quality of their products by implementing validated screening methods.
• Regulatory Bodies: Establishing and enforcing standards for the detection of veterinary drug residues in milk and milk products.
• Laboratories: Conducting accurate and reliable testing to detect residues of veterinary drugs, ensuring compliance with regulatory requirements.
• Food Safety Professionals: Implementing best practices for the validation of screening methods, contributing to overall food safety and public health.

Detailed Content

The standard spans 44 pages and covers a wide range of topics, including:

• Introduction: Overview of the importance of detecting veterinary drug residues in milk and milk products.
• Scope: Definition of the standard's applicability and limitations.
• Terms and Definitions: Clarification of key terms and concepts used throughout the document.
• Validation Process: Step-by-step guidelines for validating qualitative screening methods, including criteria for method performance and acceptance.
• Documentation and Reporting: Requirements for documenting and reporting validation results, ensuring transparency and traceability.
• Annexes: Additional resources and examples to support the implementation of the guidelines.

Benefits of Implementing This Standard

By adopting the PD CEN ISO/TS 23758:2021 standard, organizations can achieve several key benefits:

• Enhanced Food Safety: Reliable detection of veterinary drug residues helps protect consumers from potential health risks.
• Regulatory Compliance: Ensures that dairy products meet national and international safety standards, avoiding potential legal and financial repercussions.
• Consumer Trust: Demonstrates a commitment to quality and safety, fostering consumer confidence in dairy products.
• Operational Efficiency: Streamlined validation processes and clear guidelines help laboratories and producers operate more efficiently and effectively.

Conclusion

The PD CEN ISO/TS 23758:2021 standard is an indispensable tool for anyone involved in the dairy industry, food safety, and regulatory compliance. By providing detailed guidelines for the validation of qualitative screening methods, this standard ensures that veterinary drug residues in milk and milk products are accurately detected, safeguarding public health and maintaining the highest standards of quality.

PD CEN ISO/TS 23758:2021

This standard PD 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 is classified in these ICS categories:

• 67.100.01 Milk and milk products in general

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.