Oral dosage form is a maximally prescribed formulation amongst all possible pharmaceutical products. Formulation of tablet is multistep process where each step has meaningful effect on quality of final product. So, it is necessary to identify the important unit operations in process of tablet manufacturing which significantly affect the efficacy and safety of formulation. In present work, the blending step is elaborated in detail to check the impact of the same on the quality of tablet dosage form. The concept of QbD was employed on blending process with identification of QTPP and CQAs. In risk estimation matrix various independent factors were finalized having impact on CQAs of blending. Further, screening of critical factors was done using placket burmann design. Full factorial design (3*2) was used further to check the relation of identified critical factors (blending speed and blending time) on selected CQAs (blend uniformity & RSD). From overlay plot, control space was outlined and the range of risk free processing parameters was fixed. So, if blending of drug-excipients blend is performed in these specified conditions, the quality of blend (uniform mixing) can be assured. This blend can be charged further into granulation step.

QbD, Blending, Placket burmann design, Blend uniformity, %RSD