What Is method Validation and how much types of it ?

Question

Accepted Answer

Method validation is the process of demonstrating that an analytical method is suitable for its intended use.

Method validation ensures that the method is accurate, precise, specific, and robust.
It involves evaluating various parameters such as linearity, accuracy, precision, specificity, limit of detection, limit of quantitation, and robustness.
There are different types of method validation, including validation of analytical methods, bioanalytical methods, and microbiological methods.
Analytical method validation involves validating methods used for chemical analysis, such as HPLC, GC, spectrophotometry, etc.
Bioanalytical method validation is specific to the analysis of drugs and their metabolites in biological samples.
Microbiological method validation is performed to validate methods used for microbial testing, such as sterility testing, microbial limit testing, etc.

Accepted Answer

The process of ensuring a pharmaceutical test method suitable for intended use.

Interview Questions Asked to Senior Researcher at Other Companies