In Process Validation as we know that first stage is process design, Some of the points which are discussed during the process design are as follows , so let us check it out one by one.
Use Design of experiment (DOE) to develop the process by different factors such as :
By Revealing relationship between the various variable inputs such as characteristics of components or process parameters and between the resulting outputs such as process material, intermediate or the final product.
Also take into account the risk analysis to screen various variables in the design of experiment.
Based on the Design of experiment (DOE) results decide the range of the Incoming components quality, Parameters of equipment and In-process material quality attributes.
Take the data of lab or the pilot scale into consideration to determine the performance at commercial scale.