What is an Analytical Test Method Validation?

What is analytical test method validation


Is the verification that the process and instructions used to confirm that the analytical test method procedure employed for a specific test is suitable and validated for its intended use.  The analytical test method validation is described in the USP and other reference documents.

The United States Pharmacopeia (USP) <1225> defines method validation as “a process by which it is established, through laboratory studies, that the performance characteristics of a method meet the requirements for its intended analytical applications.”

Results from method validation can be used to judge the quality, reliability, and consistency of the analytical results.

It is an integral part of any good laboratory practice (GLP) because brings trust to the reported results.

The FDA definition of the Analytical Test Method Validation

The FDA guidelines define a Methods Validation: “Establishing documented evidence that provides a high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.”

Statutory and Regulatory Requirements – Analytical Test Method Validation

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 Method Validation Protocol:

Option 1. You Can Create a Great Analytical 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 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 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!