An overview of Method validation

 

In this article, we will learn method validation fitness for purpose of the analytical method

• What is analytical method validation?
• What is the difference between method validation and verification? 
• Why is the method validation necessary?
• When should methods be validated or verified? 
• How should the method be validated?

What is analytical method validation?

Different international documents have given the method validation definition like as per, 

ICH Q2: the analytical procedure is to exhibit that it is suitable for its intended purpose. 

United States of pharmacopeia USP: the process by which it's established by laboratory studies that the performance characteristics of the procedure meet the requirement for the intended analytical application 

ISO 9000: confirmation, through the stipulation of objective proof that the demand of specific intended use for application have been fulfilled 

ISO/IEC 17025: confirmation, by examination and provision of objective proof that the particular requirement about the specific intended use is fulfilled

International vocabulary of metrology: confirmation where the defined requirements are adequate for the intended use.

Method validation is the process of determining an analytical requirement and confirming that the method under consideration has capacities consistent with the application requirements. Inherent in this is the need to evaluate the performance of the methods. The judgment of method suitability is important. In the past, method validation led to concentrating only on evaluating characteristics of the performance. 

What is the difference between method validation and verification?

As per the United States of pharmacopeia USP, the verification has processed the assessment of whether the procedure can be used for its intended purpose, under the actual conditions of utilization for a specified drug substance or product matrix. 

Method validation is the process established by laboratory studies, that the performance characteristics of the procedure meet the specification for the intended analytical application. While method verification is the process of the evaluation of whether the procedure can be used for its intended goal. In short, method validation is the establishment while method verification is an assessment of an analytical method that can be used for an intended purpose. 

Why is method validation necessary?

By the analytical method, we checked the quality of the material, product. The analytical method is a way of valuing goods for trade purposes

When should methods be validated or verified?

A method should be validated when it is necessary to demonstrate that its performance characteristics are adequate for use for a particular purpose, for instance, laboratories shall validate non-standard methods, laboratory design or developed methods, the standard methods used except for their intended scope, amplification, and modification of the standard method.

Validation is also expected when it is needed to illustrate the equivalence of results obtained by two methods. For example, a newly developed method and an existing standard or regulatory method. For standard methods such as those published by USP, EP, ISO, or ASTM, validation by the laboratory using the method is not necessary. However, the laboratory has to verify the performance of the method.

How should the method be validated?

Once the primary method development is concluded there are two approaches to the method validation the interlaboratory comparison approach and a single laboratory approach. Regardless of the approach, it is the laboratory using a method that is responsible for ensuring that it is fit for the intended use. 

Inter-laboratory approach: it has been published in the literature regarding method validation by dedicated interlaboratory comparison often referred to as collaborative studies or cooperative studies, if a method is being formed which will have wide ranges of use probably as a published standardized procedure, then a collaborative study comprising the group of laboratories is probably the preferred way of testing validation. Published method validated in this way is demonstrated to be robust.

Single laboratory approach: laboratories will from time to time find that a method is required but not available as a published standard. If the method is developed for use in one laboratory, for instance, because there is no common interest in the method or because other laboratories are competitors then a single laboratory approach is appropriate. 

Summary

Method validation of analytical is the process by which it's established by laboratory studies that the performance characteristics of the procedure meet the requirement for the intended analytical application. Method verification of the analytical method processes the evaluation of whether the procedure can be used for its intended goal. The method should be validated for the newly established method by the laboratory. Method verification should be performed for the published standard method by regulatory bodies. There are two method validation approaches, inter-laboratory, and single laboratory