Test Method Validation

 Test Method Validation

Test Method Validation is another regulatory mandate by FDA that confirms whether the analytical procedure employed for a specific test is suitable for its intended use or not. This validation is specifically used to optimize the testing procedures for medical devices and equipments. ADB Consulting by using its comprehensive methodologies of test method validation produces evidence that assures that the particular test method is capable of fulfilling certain requirements for a specified intended use.
We take into account the requirements and performance parameters of the analytical method to perform a series of experiments designed to estimate certain types of analytical errors. Our highly responsive error assessment procedures make the entire validation process seamless for the medical equipment manufacturers.
ADB can assist you with validation of all methods used in testing raw materials, in-process materials, final containers, and excipients. Test method validation is essential for adherence to Good Laboratory Practice (GLP) regulations and Current Good Manufacturing Practice (cGMP), and, therefore, must be taken as seriously as any other validation procedure.
 

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