PD CEN/TS 16800:2020 - Guideline for the Validation of Physico-Chemical Analytical Methods

Unlock the potential of your laboratory with the PD CEN/TS 16800:2020, a comprehensive guideline designed to enhance the accuracy and reliability of your physico-chemical analytical methods. Released on January 8, 2021, this standard is an essential resource for professionals seeking to validate their analytical techniques with precision and confidence.

Overview

The PD CEN/TS 16800:2020 serves as a pivotal document for laboratories and research facilities aiming to ensure the integrity of their analytical results. With a total of 52 pages, this guideline provides a detailed framework for the validation process, ensuring that your methods meet the highest standards of quality and reliability.

Key Features

• Standard Number: PD CEN/TS 16800:2020
• Pages: 52
• Release Date: January 8, 2021
• ISBN: 978 0 539 12940 3
• Status: Standard

Why Choose PD CEN/TS 16800:2020?

In the ever-evolving field of analytical chemistry, maintaining the accuracy and reliability of your methods is crucial. The PD CEN/TS 16800:2020 guideline provides a robust framework for validating physico-chemical analytical methods, ensuring that your laboratory's results are both credible and reproducible.

Comprehensive Validation Process

This guideline outlines a comprehensive validation process, covering all critical aspects of method validation. From precision and accuracy to specificity and robustness, the PD CEN/TS 16800:2020 ensures that every facet of your analytical methods is thoroughly evaluated and validated.

Enhanced Method Reliability

By adhering to the standards set forth in this guideline, laboratories can significantly enhance the reliability of their analytical methods. This not only boosts confidence in the results but also ensures compliance with industry regulations and standards.

Industry-Standard Compliance

The PD CEN/TS 16800:2020 is recognized as a standard, making it a trusted resource for laboratories worldwide. By implementing the guidelines, you ensure that your methods are in line with industry best practices, facilitating smoother audits and inspections.

Who Can Benefit?

This guideline is indispensable for a wide range of professionals, including:

• Analytical Chemists
• Laboratory Managers
• Quality Assurance Specialists
• Regulatory Compliance Officers
• Research Scientists

Conclusion

Incorporating the PD CEN/TS 16800:2020 into your laboratory's practices is a strategic move towards achieving excellence in analytical chemistry. With its detailed guidelines and comprehensive validation process, this standard is your key to ensuring the highest level of accuracy and reliability in your physico-chemical analytical methods.

Embrace the future of analytical validation with the PD CEN/TS 16800:2020 and elevate your laboratory's capabilities to new heights.

PD CEN/TS 16800:2020

This standard PD CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods is classified in these ICS categories:

• 13.060.50 Examination of water for chemical substances

This document describes an approach for the validation of physico-chemical analytical methods for environmental solid matrices and water.

The guidance in this document addresses the initial description of the method and two different validation approaches, in increasing order of complexity. These are:

1. method development, if the method is developed by the laboratory, or conditions of adoption, if the method is a standardized protocol adopted by the laboratory;

2. validation at the level of single laboratories (within-laboratory validation);

3. method validation at the level of several laboratories (between-laboratory or inter-laboratory validation), with a focus on methods that are sufficiently mature and robust to be applied not only by a few expert laboratories but by laboratories operating at the routine level.

The concept is strictly hierarchical, i.e. a method shall fulfil all criteria of within-laboratory validation before it can enter the validation protocol of the between-laboratory.

This document is applicable to the validation of a broad range of quantitative physico-chemical test methods for the analysis of water (including drinking water, surface water, groundwater, waste water, marine water), and of solid environmental matrices, such as soil, sludge, liquid and solid waste, sediment and biota. It is intended for standardized protocols adopted by a laboratory, and either for test methods aiming at substances that have recently become of interest or for test methods applying recently developed technologies.

The minimal requirements that are indispensable for the characterization of the fitness for the intended purpose of an analytical method are: selectivity, precision, trueness, performances characteristics and measurement uncertainty. The aim of validation is to prove that these requirements are met.

In this document after the definitions (Clause 3) and description of the principles (Clause 4) a toolbox is given describing the relevant performance characteristics in the validation process.

Clause 7 and 8 focus on the within laboratory validation process (V1) and Clause 9 on the interlaboratory validation process (V2). Clause 7 and 8 describe largely the same processes, but differ in approach for establishing the LOQ.

Reporting of the results of the validation studies is addressed in Clause 10.