What a Qualified Person Actually Certifies, and What They Refuse To

What is the QP actually asserting?

That this specific batch conforms to its marketing authorisation and was made under GMP. That is a narrower and heavier claim than it appears. Narrower, because the QP is not vouching for the commercial wisdom of the product or the elegance of the process; the assertion is about compliance of a batch. Heavier, because it is made personally and recorded, and because the QP must have sufficient knowledge of the whole supply chain to make it honestly. Where manufacture or testing happened at multiple sites, possibly in different countries, the QP performing final certification must be satisfied about all of it, not merely about the paperwork that reached their desk.

When does a QP decline to certify?

Whenever the assertion cannot honestly be made, and the point of the role is that this decision is theirs. Common triggers are an open deviation whose product impact has not been assessed, missing or unreconciled analytical data, a change implemented without approval, an unqualified supplier in the chain, or an out-of-specification result closed without a defensible investigation. The commercial pressure at that moment is real: a batch on hold has a value and often a patient waiting. This is precisely why the law makes the certification personal. A QP who can be instructed to sign is not performing the function the legislation describes, and an inspector will look for evidence of exactly that dynamic.

How should the role be positioned?

With independence that is visible in the reporting line, not merely asserted in a job description. The QP needs unrestricted access to batch documentation, deviation records and supplier qualification files, the standing to hold a batch without needing permission, and a documented escalation route for disagreement. Where a QP is contracted rather than employed — common and entirely legitimate for smaller operations — the contract has to give them enough time and access to know the supply chain properly, and the manufacturer must accept that they may say no. A QP retained on terms that make refusal awkward has been hired for the signature rather than the judgement.

Frequently asked questions

Can a consultant act as our QP?

Yes. Contracted QPs are common and legitimate, particularly for smaller manufacturers and importers. What matters is that they are named, have genuine access to the information the role requires, and have sufficient contracted time to exercise judgement rather than rubber-stamp.

Is there an FDA equivalent of the QP?

No direct equivalent. US regulation places batch release responsibility on the quality unit rather than on a named individual with personal legal accountability. This is one of the structural differences US sponsors most often discover late when entering the EU.

Can a QP certify a batch manufactured outside the EU?

For imported products a QP in the EU must certify the batch before release, and must be satisfied that manufacture and testing met standards at least equivalent to EU GMP. That is why import operations put so much weight on supplier qualification records.

Sources

1. EudraLex Volume 4, Annex 16 — Certification by a Qualified Person and batch release, European Commission. health.ec.europa.eu
2. Directive 2001/83/EC on the Community code relating to medicinal products for human use, European Union. eur-lex.europa.eu

Pending scientific review. This briefing summarises published regulatory guidance and has not yet been signed off by a named subject-matter expert. Verify against the primary sources below before relying on it.

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