2 . 5 Control Strategy

A control strategy is designed to ensure that a product of required quality will be produced consistently .The elements of the control strategy discussed in Section P . 2 of the dossier should describe and justify how in-process controls and the controls of input materials ( drug substance and excipients ) , intermediates ( in-process materials ) .These controls should be based on product , formulation and process understanding and should include , at a minimum , control of the critical process parameters1 and material attributes .