**2. Noncompendial analytical method validation**

The objective and plan of work should be clearly defined prior to start the work. This data is based on scientific findings from the method development and Optimization. The validation of results should be obtained by approved protocol. Then sponsor must follow cGMP's which includes detail procedure, validation characteristics and acceptance criteria by the use of qualified instrumentation. All the protocols of drug substance and product analytes in respective matrices should be prepared and followed. All the results of validation studies, application should be included.
