Overview
![](/assets/images/picto-drapeau-france-3a76576a5d60a512053b4612ab58dae5.png)
ABSTRACT
It is now obvious to all laboratories that analytical methods must be validated. It is for this reason that analytical laboratories have now acquired expertise, sometimes quite substantial, in validating methods. However, it does not mean that the achievement of validation studies itself is not problematic. This article presents a review of the various existing drawbacks and proposes a well-established solution based on one user-friendly graphical statistical tool: the accuracy profile. The different steps and computations, that are useful for building an accuracy profile, are described in detail. They come with a spreadsheet application.
Read this article from a comprehensive knowledge base, updated and supplemented with articles reviewed by scientific committees.
Read the articleAUTHOR
-
Max FEINBERG: Agricultural engineer, PhD in chemistry, - Chemometrics Consultant
INTRODUCTION
Analysts are now very familiar with method validation and, over the last 10 or 15 years, have acquired a good deal of experience in this field. But why has – method validation become such an important concern for analysts –? The answer lies in the development of quality assurance in laboratories.
The very principles of quality assurance are well known and codified in very general standards published by the International Organization for Standardization (ISO). They emphasize that the quality of products or services supplied by a company – such as test results – is intended to satisfy a customer's needs. Quality assurance is anything that can individually or collectively influence the result of an analysis.
Conceptually, it is the set of measures to be taken to ensure that the results supplied will be of the quality required for the end-user's intended use. In practice, depending on the laboratory's field of activity, each manager can draw on a number of standards that provide more specific guidelines for organizing quality assurance. Today, there are three main standards governing the life of analytical laboratories:
The ISO/CEI 17025 standard, which leads to accreditation, i.e. verification of a laboratory's competence and ability to carry out analyses; this is a very general standard, of interest to many types of laboratory;
Good Laboratory Practice (GLP) applies to laboratories involved in the development of any new chemical molecule with potential effects on human health or the environment, such as drugs, pesticides, etc. It is a mandatory requirement for pharmaceutical laboratories;
The ISO 15189 standard, which supplements the "Guide de bonne exécution des analyses" (GBEA) designed specifically for medical laboratories and specifies how they can be accredited.
All these texts assert the need to validate methods, but without explaining how to go about it. For this reason, numerous guides, recommendations, industry standards and guidelines have been published to help analysts carry out validation studies. Unfortunately, they often contain inconsistencies, both in the vocabulary used and in the statistical methods proposed, and experience shows that the procedures generally proposed pose a problem when it comes to making the final decision. So the practical question of how to validate a method remains a matter of debate.
This article is a proposal for a universal, more coherent and operational approach based on a single tool: the accuracy profile. It applies to quantitative analysis methods only.
Exclusive to subscribers. 97% yet to be discovered!
You do not have access to this resource.
Click here to request your free trial access!
Already subscribed? Log in!
![](/assets/images/logo-eti-286623ed91fa802ce039246e516e5852.png)
The Ultimate Scientific and Technical Reference
KEYWORDS
method validation | uncertainty | statistical techniques | development of numerical applications
This article is included in
Laboratory quality and safety procedures
This offer includes:
Knowledge Base
Updated and enriched with articles validated by our scientific committees
Services
A set of exclusive tools to complement the resources
Practical Path
Operational and didactic, to guarantee the acquisition of transversal skills
Doc & Quiz
Interactive articles with quizzes, for constructive reading
Validation of quantitative analysis methods using the accuracy profile
Bibliography
Software tools
There are few software packages dedicated to method validation. Arlenda ( http://www.arlenda.com/ ) has developed one called "e-noval®". It uses the accuracy profile and produces a certified report. Its originality lies in the fact that it operates via the Internet (Web-based solution): the user copies the data into an Internet interface,...
Websites
AOAC (Association of Official Analytical Chemists): originally American, this association of analysts has become international. In addition to its standardizing role, it validates methods according to various protocols http://www.aoac.org/
EURACHEM, a network of European organizations whose aim is to set up a forum for the traceability...
Standards and norms
Association française de normalisation Afnor
- Water quality – Protocol for initial assessment of method performance in a laboratory - NF T90-210 - 2009
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais - NF EN ISO/CEI 17025 - 2005
- Laboratoires d'analyses de biologie médicale....
International Organization for standardization ISO
Exclusive to subscribers. 97% yet to be discovered!
You do not have access to this resource.
Click here to request your free trial access!
Already subscribed? Log in!
![](/assets/images/logo-eti-286623ed91fa802ce039246e516e5852.png)
The Ultimate Scientific and Technical Reference