For a product analytical procedure has been using since 2 years. Now it is proposed to validate the procedure. How to proceed and what are the supporting documents required…?
Thanks in advance…
First you should select which analytical procedure for that product is to be validated, whether, it is for Assay, Dissolution, Impurities quantification, Residual solvents etc. Once the test procedure to be validated is known, plese select the paramters to be validated as per Regulatory / ICH Guidelines. This would be based on whether the analytical proedure is pharmacopoeial or in-house (No-pharmacopoeial). Write a protocol of Analytical method validation with predefined ‘Acceptance criteria’. And then follow the protocol to perform method validation.
Supporting documents would be Validation protocol, Raw data collected during validation including chromatogrmas (if it is Chromatographic method such as HPLC, GC, LC-MS/MS etc.), Details of Reference standards and working standards to be used & its COAs, Reagents, Chemicals, Solvents to be used, Information on IQ, OQ, PQ of the Analytcal instruments to be used for method validation (such as Weighing balance, HPLC, GC units) and its calibration records etc.