AN UPDATED REVIEW: ANALYTICAL METHOD VALIDATION

Ritesh Kumar Srivastava* and S. Senthil Kumar

ABSTRACT

The method validation is the process by which it is established that performance characteristics of the method meet the requirements for the intended analytical applications. Methods need to be validated or revalidated before their introduction into routine use at the manufacturing unit after the drug development. To comply with the requirements of GMP, pharmaceutical industries should have an overall validation policy which documents how validation will be performed. Method validation is defined as the process of proving that an analytical technique is acceptable for the intended use and this is an important requirement for analytical purpose. Result from method validation can be used to judge the quality, reliability and consistency of analytical data. It can further help to avoid costly and time consuming exercises in analytical technique. Validation is an act of proving that any procedure, process, equipment, material, activity or system performs as expected under given set of conditions and also give the required accuracy, precision, sensitivity, ruggedness, specificity degradation path and sensitivity of the analytical method. The review focused on the concept, strategy and importance of analytical method validation and applicability in the pharmaceutical industry.

Keywords: Validation, API, USP, ICH guidelines, SOP, Impurity, Quality control.