Studies in Process Validation of Ranitidine Hydrochloride Tablet 75 mg Dosage Formulation

Documented evidence with a high degree of assurance that a process will consistently produce product, meeting its predetermined quality attributes is nothing but a process validation. In short process validation is checking of reproducibility of result. The critical process parameter was identified and evaluated by challenging its lower and upper release specification. The three process validation batches (PVB1, PVB2, PVB3) of same size, method, equipment and validation criteria was taken. The critical parameter involved in blending, compression, coating for our Ranitidine tablet were identified and evaluated as per the validation master plan. From the result we have found that in the same environmental condition there was no significant batch to batch variation and all the parameter studied were in accordance with the BMR.