Responsible Person services for GDP wholesale distribution

Every holder of a wholesale distribution authorisation in the European Union must have a Responsible Person available. The role carries personal accountability and it cannot be left vacant. Truex Consultancy provides qualified professionals who take the role on an interim, part time or standby basis.

The EU guidelines on good distribution practice place a specific set of duties on the Responsible Person. In practice these come down to a small number of things an inspector will ask about directly.

Approving suppliers and customers, and being able to show the checks behind each approval. Releasing returned medicines back to saleable stock, or refusing to. Overseeing the recall system and being able to demonstrate that it has been tested. Running the self inspection programme and following up on what it finds. Ensuring complaints are handled and closed. Making sure training is delivered and recorded. Overseeing temperature control and the qualification of transport. Ensuring the requirements around falsified medicines are met. Approving any activity that is subcontracted, and holding a written agreement for it.

The RP does not have to perform all of this personally. The RP does have to be able to show that it happened, and that they exercised judgement over it.

Four patterns account for most of the findings we see.

An RP in name only. Someone is named on the licence but makes no recorded decisions. The file contains no evidence of the RP approving suppliers, reviewing self inspections or overseeing recalls. An inspector reads this as a licence held without oversight.

No deputy. The RP takes three weeks of leave and no one has the authority to release stock. Operations either stop or continue without proper approval. Neither outcome is defensible.

Too little time. The RP has a full time role elsewhere in the business and treats the RP duties as an evening task. The self inspection programme slips, complaints stay open, and the recall test never happens.

No handover when the RP leaves. The successor inherits no reasoning, only a signature history. Every previous decision becomes unverifiable.

A named, qualified Responsible Person with the relevant experience for your product range and distribution model. An agreed monthly time budget, so both sides know what is covered. A documented decision log, so the reasoning behind approvals is visible and survives any change of person. A self inspection programme that runs on schedule. Direct availability by phone for the decisions that cannot wait.

We also review the arrangement itself at least once a year. If your business changes, for example by adding a new product category or a new market, the RP arrangement is adjusted rather than left to drift.

Can a Responsible Person work part time?

Yes. The requirement is availability and competence, not a full time contract. What matters is that the RP has enough time to perform the duties properly and can be reached when a decision is needed. We agree a time budget in advance and review it if your volumes change.

Does the RP have to be based in the Netherlands?

The RP must be contactable and able to fulfil the duties for the licence in question. For a Dutch wholesale distribution authorisation this means being available to the site and to the competent authority. Our RPs are based in the Netherlands.

What happens if our current RP resigns?

Notify the competent authority and appoint a replacement without an uncovered gap. This is the situation we are called into most often. We can usually provide standby cover within one to two weeks, which gives you time to recruit properly rather than in a panic.

What is the difference between a QP and an RP?

A Qualified Person certifies batches of medicinal products for release under a manufacturing authorisation. A Responsible Person oversees compliance with good distribution practice under a wholesale distribution authorisation. They are separate roles under separate legislation, although one individual can sometimes hold both.

Can you also act as deputy to our own RP?

Yes. Many clients keep their internal RP and use us purely as the named deputy. It is the least expensive way to remove the single point of failure from your licence.