Control strategy

The planned set of controls, derived from product and process understanding, that assures process performance and product quality: material attributes, process parameter ranges, in-process controls, specifications, facility and equipment controls and monitoring (ICH Q8, Q10 and Q11). Japanese CMC documents use the term as ICH does. It links development to commercial manufacturing: process validation demonstrates the strategy, and continued process verification monitors it. When a Japanese reviewer asks how an attribute is controlled, point to the specific element of the control strategy, not only to release testing.