Introduction
For both conventional batch manufacturing and continuous manufacturing, if no PAT is used nor a robust real time release strategy is put in place, the quality of the manufactured medicines needs to be assessed based on existing release standards and methods, and adequate samplings. These are tests with ‘Pass’ or ‘Fail’ statements, that apply for the whole batch, based on a limited number of adequately sampled specimen. As these tests happen at the end of the manufacturing process, how to manage the production to be sure these tests pass?