For years, most pharmaceutical companies have treated inspection readiness like a finish line. You build the facility. You qualify the equipment. You prepare the documentation. Then you get ready for the inspection. But the FDA’s new PreCheck Pilot Program suggests that approach may no longer be enough.
The program introduces earlier regulatory engagement with manufacturers during the development of new facilities, giving the FDA visibility into how sites are designed, how quality systems are structured, and how companies plan to operate long before commercial production begins.
And while much of the conversation around PreCheck has focused on faster approvals and strengthening domestic manufacturing, the bigger story may be how it changes the way companies approach inspection readiness. Read More >
