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Top Mistakes in Analytical Method Validation and How to Avoid Them?



Top Mistakes in Analytical Method Validation and How to Avoid Them?

The pharmaceutical industry depends heavily on analytical method development to validate the safety and efficacy of drug compounds. It is a regulatory requirement that shows FDA and other regulatory agencies that the method used for testing a drug compound is suitable for its chosen purpose. What method validation entails during the process of drug development is to primarily create a scientific proof for the quality, consistency, and reliability of drug compound’s behavior. These days, CRO clinical labs carry out most of these essential process, even as some of them continue to err despite access to proven practices and methodologies.

Here are the top mistakes that CROs and scientists need to avoid while setting up method validation processes and procedures.

Failure to draft the right plan

Though scientific processes are based on in-depth planning and detailed research, the failure to create the right study plan can occur. Scientists need to set up the correct methodology or qualify the equipment to get accurate results from the data collected.


Creating faulty acceptance criteria

The FDA protocols are stringent, and not setting up processes which fall within the purview of the accepted norms can lead to inaccuracy. However, the major cause for concern is not following the generic norms without evaluating the suitability of the method development process.


Ignoring Potential Interferences

When designing the analytical method validation process, ignoring the potential interferences can lead to inaccurate results. It is essential to take into consideration solvents, derivatization reagents, and other sources of interferences, especially for complex matrices to ensure the result is not affected.


Ignoring changes in samples

Sample degradation can occur due to several reasons, many CRO clinical scientists end up ignoring this vital fact. Hence, it becomes imperative to include experiments demonstrating the effectiveness of the method for stability analysis.

Incorrectly using robustness studies

Robustness studies measure the capacity of a drug compound to remain unaffected by small or minute variations. Though analytical validation is incomplete without robust studies, the mistakes are made:

During the investigation processes which usually happen when a new method is used for validation

Lack of awareness or ignoring the right factors required to test the robustness. Scientists need to review all the steps when choosing robustness factors for their method validation

Under-utilizing the robustness study results or the data collected to create a meaningful discussion or better risk assessment.

Utilizing non-validated methods for critical decision making

FDA analytical method validation offers comprehensive guidelines. Sometimes, in the name of innovation, it is easy to ignore validated methods. The inaccurate results may be used to reach critical decisions. Hence, following set procedures can prevent potential harm to the intended user and the pharmaceutical company invested in the drug compound.


Method validation is a complex procedure requiring optimization of resources to speed up the process of drug development. As the process proceeds, each step requires validation. However, changes are an accepted norm. It is essential to document the expected changes that may occur. Set up the correct processes to validate the drug compound for the correct and accurate results.

Preeti Roy is a passionate blogger and writer , she share information and guidance on topics to make your business at top notch in your marketing position.