Important criteria for Analytical Method Validation

The process of ensuring the fundamental efficiency and quality of pharmaceutical drugs, method validation has evolved as an essential part of drug product reliability. Although the concept of method validation is not new, the industry is embracing its features in various activities such as analytical methods. This helps in assessing the quality of drug product and proves its effectiveness in a particular field. 

Analytical Method Validation

In this article, we will assess the criteria required for analytical method validation in the pharmaceutical industry.

Understanding Analytical Method Validation

Analytical method validation is a procedure utilized to ensure that an analytical activity is suitable for the use it is being tested for. The results obtained from this validation process are utilized to know the consistency, reliability, and quality of an analytical procedure.

It is necessary to validate analytical methods for the following conditions:

  • Before the method is being introduced for regular use.
  • For changed conditions and relevant validations.
  • For changes in the method which fall outside originally deduced scope.

Guidelines for Analytical Method Validation

The analytical method validation for a particular pharmaceutical product is developed after evaluating various suitable procedures. However, before a method validation process is decided, it is necessary to keep in mind that the process should lead to finding the relevant outcome. In this case, it is finding out whether the product is appropriate and safe for the intended use or not. 

Here are some guidelines for analytical procedures that can help in successful validation:


Any new analytical method is required to meet certain validation guidelines, which start with repeatability. It should be known how many times the measurement is repeated, and under which circumstances and environment. FDA says that this number of repeatability should be not fewer than 3 but it can be 6 or more than that.

Precision also includes the reproducibility of the method, which means precision in different results obtained from different laboratories. Reproducibility is specifically important for the procedures being considered for standardization.


Robustness only measures whether a method will successfully execute with small variations or not. Needless to say, robustness is evaluated during development to know the reliability of the method when exposed to variations. Here, various suitability parameters are formed to ensure that the method is reliable to use under different conditions.

Suitability Testing

Every analytical method is eventually tested for its suitability, which means the procedure should be assessed as suitable for the envisioned purpose. Here, it is required to find out the suitability of two or more compounds that are present in a given sample. However, one compound which is the actual analyte should be quantitated and identified. 

Other Factors: Specificity, Linearity, Range, and Accuracy

While the above three are significant for test method validation, there are many other guidelines: 

  • Knowing whether an analytical procedure is meant for a specific use.
  • Understanding if an analytical method will achieve results in relevance to given analyte concentration.
  • Analyzing the accuracy of an analytical method based on specificity, linearity, and precision.

To prevent unreliable and irreproducible outcomes, certain guidelines are followed for analytical method validation. These guidelines ensure that a drug compound or product is suitable for its intended use. Hence, by utilizing the above considerations you can evaluate the validity of your analytical procedure.

Also Read- NebioLab Drug Development Techniques: Analytical Laboratory Services

Comments are closed