A manufacturing or importation authorisation is conditional on continued GMP compliance. That single sentence is why GMP is a board-level matter rather than a departmental one: the licence to operate is contingent, and the contingency is assessed by someone outside your organisation on a schedule you do not set.
The failure mode is rarely dramatic. It is gradual: an audit slips a quarter, a re-qualification rolls forward, a CAPA is closed on retraining without a confirmed cause. Each decision is defensible on the day it is taken. Read together by an inspector two years later, they support a finding that the quality system is not effective — which is systemic, and far harder to answer than any individual item.
The asymmetry matters commercially. The cost of closing a gap early is a project. The cost of closing it after a finding is a project plus a deadline you did not choose, plus the visibility of a published outcome, plus whatever the interruption did to supply. Same work, different price.
There is a second-order effect executives consistently underestimate: what a quality culture signals to the people in it. Where raising a problem is penalised, problems stop being raised. Inspectors are trained to notice that, and the resulting findings are about management rather than about the event.