What Are The Basic Principles Of Method Validation?

The bioanalytical method validation of an analytical procedure is a technical
process established by laboratory sciences. It gauges whether the performance
characteristics of the product meet the requirements of its intended use. There are
various reasons for carrying out method validation, for example, regulatory
requirements, quality control, and compliance. It is necessary to confirm through
the analytical method transfer that the product displays verifiable accuracy, is
sensitive, specific, is easily reproduced, and is suitable for human use.

The most common procedure followed in method validation is the following:

• Planning and deciding on the method validation experiments
• Writing and approval of method validation protocol
• Execution of the method validation protocol
• Analysis of the method validation data
• Reporting the analytical method validation
• Finalizing the analytical method procedure

There are specific principles that the ICH method validation should consider
while being conducted. They are:

1. The tests to be performed must be specified in standard tests methods
2. The standard test methods in pharmacopeial methods or developed methods of
testing as approved by the National Regulatory Authority to be used.
3. The references employed in the analysis requires document purity and
characterization.
4. The results should be accurate, legible, have a reproductive capacity, be original,
and archived for a set period. It should also comply with the National Regulatory
Authority’s regulations
5. The procedure should be a part of a continuous confirmation process so that it
meets a predefined purpose.
6. The degree of verification will depend on the outcome and the risk assessment.
7. The technicians should have suitable qualifications to carry out this process
8. The data acquired must fall under the criteria of Good Anything Practices (GxP)
and follow the principles of good data and management practices. The data
safekeeping should adhere to good record management practices.
9. The computers and technology that are processing information should comply
with the rules laid out for them.
10. The process of data sampling should be given the utmost attention. The

description of data sampling should be detailed as it can have a vital impact on the
test results.
11. The method validation report should include failures and errors. It shouldn’t be
limited to the passing result as it may display biased reliability and versatility of
the product.

When the method validation process has ended, all the data should be evaluated to
obtain a comprehensive report with the conclusive statement of success or failure.
The data received from the procedure must be assessed as soon as possible to
ensure a constant and steady process. If an error is found, it must be resolved
immediately to ensure that the following experiments are not affected by it. If the
validation is executed successfully, a final analytical procedure will be procured,
which will be utilized by the laboratory to aid analytical work for future drug
substances or products.

While the principles listed in this article are the ones that are commonly followed
and accepted, however, it is up to the manufacturer to decide validation protocol
and procedures that are best suited for their product.

Note: The content published in this post is claimed to be original and belongs to
the author.

Reference Link: https://www.fuzia.com/article_detail/160749/what-are-
the-basic-principles-of-method-validation