The decision is usually made in passing
The question arises in almost every company that holds its first marketing authorisation or is expanding its portfolio. It is rarely answered properly — usually, whatever involves less effort at the time wins.
Yet this is not about in-house versus external. It is about four points that need to be clear beforehand.
The obligation remains with the marketing authorisation holder
Outsourcing hands over the task — not the responsibility. The marketing authorisation holder remains accountable to the authority. This is why the pharmacovigilance agreement determines how robust the arrangement is: who carries out which step, how handovers are documented, how the service provider is audited.
The workload cannot be planned, the deadlines can
Case numbers fluctuate. An extension of indication, a publication, a signal procedure — the workload can shift within a few weeks. The deadlines stay where they are.
For an in-house solution this means: you must be able to cover the peak, not the average. For an external one: the contract must cover the peak, not the normal volume.
The QPPV function needs a named person and a reliable deputy
A QPPV without a trained deputy is a single point of failure. If they are absent, the role is vacant — and that is visible in every inspection.
This is one of the points where an external solution can have a structural advantage: where several people can fill the function, deputising is genuinely in place.
The PSMF is only as good as its maintenance between two inspections
A PSMF that is only updated before the inspection does not describe the system but an aspiration. Anyone who outsources should therefore specify who maintains it on an ongoing basis — and how changes within the company find their way into it.
The real test question
It is not “in-house or external”, but: can you name, for each of these four points, who is responsible for it and where this is documented? If so, both routes work. If not, neither does.