Sixth development phase: establishing the control strategy
Quality risk management applied to pharmaceutical product development

The purpose of the control strategy implemented is to define the specifications for the different components of the formula, the different process parameters, the controls to be followed during the manufacturing process or In-Process Controls (IPC) and the specific control criteria for the finished product.

The control strategy must be interpreted as a combination of input variables relating to material controls, controls, monitoring of the various stages of the process and finished product specifications guaranteeing the expected quality of the finished product.

In this example, the control strategy is shown in table 21 .