Analytical Method Validation
About Analytical Method Validation
Analytical method validation is the process used to authenticate that the analytical procedure employed for a specific test is suitable for its intended use. “As per FDA method validation is define as the process of proving (through scientific studies) that an analytical method is acceptable for its intended use.
FAQ's
What is Analytical Method Validation?
Ensuring that analytical methods produce reliable and consistent results.
Why is Analytical Method Validation important?
It guarantees the accuracy and reliability of data from analytical methods.
How is Analytical Method Validation conducted?
By assessing method performance through specificity, precision, accuracy, and sensitivity tests.
What are the steps in Analytical Method Validation?
Planning, method development, validation testing, and documentation.
Who is involved in Analytical Method Validation?
The CRO, with support from laboratory and quality assurance teams.
What documentation is required for Analytical Method Validation?
Validation protocols, method performance data, and validation reports.
