All You Need to Know About Analytical Test Method Validation

What is an Analytical Method?

A technique that allows us to measure and determine the concentration qualitatively or quantitatively the composition of a chemical compound or materials either during a normal routinely sample testing or during an Analytical Test Method Validation. Read more.

What is an Analytical Test Method Validation?

Method validation is the verification that the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Read more.

What are the Analytical Performance Characteristics?

The performance characteristics of the chemical analytical processes are those quantifiable terms, which may indicate the extent of the quality of the processes.

The analytical method validation consists of the following analytical performance characteristics: Accuracy, Precision, Specificity, Detection Limit, Quantitation Limit, Ruggedness (Intermediate precision), Linearity, Range, Robustness.  Read more.

For more information refer to httpss://pdfs.semanticscholar.org/5b03/95b168eff40a79b267de263480db5020dd05.pdf

The Analytical Test Method Categories

The categories of analytical methods are Category I, Category II, Category III, and Category IV.  Read more.

Which Analytical Performance Characteristics are Required for each Analytical Test Method Category as per USP <1225>?

 For each analytical test method category, different analytical performance characteristic is needed.

 The following table describes which analytical performance characteristics is applicable to each analytical test method category:

How to Write an Analytical Test Method Validation Protocol?

The analytical method validation protocol is the document that shall verify and confirm if the selected analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures should be clearly defined and understood before initiating validation studies. Read more.

Statutory and Regulatory Requirements

Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.

The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical products with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in the USP and the NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use.

Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for the adoption of new or revised compendial analytical methods be supported by sufficient laboratory data to document their validity.