Qualified Person

What a Qualified Person actually does

The Qualified Person certifies that each batch has been manufactured and tested in accordance with GMP and the marketing authorisation before it is released to the market. That signature carries personal legal responsibility, which is why the role is defined in Directive 2001/83/EC and why the pool of eligible people is small everywhere in the European Union.

In practice the QP spends the day on the release desk: batch record review, deviation and OOS assessment, confirmation that the supply chain from starting material to finished product is under control, and the judgement calls on what can be released, what must wait, and what needs a recall discussion. At a CDMO the QP certifies for multiple marketing authorisation holders with different technical agreements; at an importer the QP relies on the audit of the third-country manufacturer.

What we look for when we screen

We check eligibility first: the education and experience requirements of Article 49 of the Directive, as implemented in the country of the licence. Then we test judgement. We ask about the last batch the candidate refused to certify, the last deviation that went to a recall assessment, and how they document reliance on other QPs under Annex 16.

We also test:

• Annex 16 in practice: reliance, sampling on import, the certification register.
• Supply-chain control: technical agreements, supplier audits, transport qualification.
• Deputy and named-on-licence experience: what the candidate has actually signed.
• IMP experience where relevant: Annex 13, blinding, comparator sourcing.
• Working style: can you hold a release when the whole site is waiting on it?

Regulations you will live with

Directive 2001/83/EC Articles 48 to 52, Annex 16, EU GMP Chapters 1 and 2, Annex 1 for sterile products, Annex 13 and the Clinical Trials Regulation for investigational products, and the national implementation of QP eligibility in each member state.

Typical employers

CDMOs certifying for multiple marketing authorisation holders, importers and parallel distributors, generics manufacturers, vaccine and biologics sites, and clinical trial supply units across the European Union.

Career path

Most QPs come from QA management or senior QC and add the formal eligibility through education and documented experience. Deputy QP is the usual first step; QP named on the licence and Head of Quality with QP responsibility follow. Salary bands and interim day rates are in the salary guide.

Permanent, interim or freelance?

Permanent QPs suit sites with a steady release volume and a licence to hold. Interim QPs cover gaps between appointments, sudden departures and peaks in release volume; the eligibility check is identical and we do it before any introduction. We place all three and tell you honestly which one your situation needs.