8.3.3. Control Strategy The control

8.3.3. Control Strategy The control strategy can include a number of interacting elements that assure full control of the product to be marketed. In the dossier the control strategy should be summarized in Module 3, Section P.5.6 with a scientific justification provided for the strategy. Additional information can be presented in other sections of the dossier (refer to Q8, Q11). Consideration should be given to the identification of potential residual risk that might remain after the implementation of the proposed control strategy and proposals for managing these residual risks. Continual improvement of the control strategy through such methods as continuous process verification might be introduced into an application using a post-approval change management plan, which would set out the applicant’s proposed regulatory outcome and expectations.