Journal of Pharmaceutical Microbiology

According to ISO, Validation is the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. Validation process an estimate is made of the representativeness, repeatability and reproducibility of the test method.

The laboratory validates non-standard methods; laboratory developed methods, and modified standard methods including use outside the intended scope and applications. Validation is conducted to confirm that the methods are fit for the intended use. The validation is documented. Validation process includes: Accuracy, Precision, Specificity, Detection Limit, limit of quantitation, linearity, range, and ruggedness or robustness.