All You Need to Know About Analytical Test Method Validation

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.

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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:

USP 1225 table analytical test method validation

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.



For more details on specific FDA expectations and how to perform an Analytical Test Method Validation, follow us.

validation templates online

Three (3) Options to Create an Analytical Test Method Validation Protocol:

Option 1. You Can Create a Great Analytical Test Method Validation Protocol, Using a Template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on How to Perform an Analytical Test Method Validation Protocols Using Our Template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create a Customized Analytical Test Method Validation Protocol.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.




Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry


Validation of compendial methods

Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!