Question 8 of 20 Fundamentals Concept
What does a Qualified Person confirm before certifying a batch in the EU?
Short answer
Before certifying, the QP must be assured that the batch was made and tested in line with GMP and its marketing authorisation, that records are complete, processes remain validated, investigations are finished enough to support release, and changes have been assessed. Only certified batches can be released to market.
Why
EU law requires every batch of finished product to be certified by a Qualified Person before it is sold or exported. Annex 16 of EudraLex Volume 4 sets out what that means. Some duties the QP must do personally, such as recording the certification in a register.
A longer list of points must be secured, and the QP may delegate that work to trained staff or third parties while relying on the quality system. Those points include that manufacturing and testing match the marketing authorisation, that the supply chain of the active substance is documented, that sites have been audited, that records are complete, that processes remain validated, that QC results meet the specification, that changes have been evaluated, and that investigations on the batch, including OOS and out of trend results, are complete enough to support certification. The QP must also be confident that ongoing complaints or recalls do not undermine the decision.
This is a personal legal responsibility, which is why a QP will ask hard questions about a deviation even when every test passed. It differs from the US model, where the quality unit as a function approves release. The QP can only rely on what the quality system produces, so a weak deviation or audit process directly weakens every certification.
A strong answer covers
- Every batch certified before release, a legal requirement
- Compliance with GMP and the marketing authorisation
- Investigations and changes resolved enough to support release
- Delegation of tasks but personal responsibility
- Reliance on the quality system must be well founded
Common mistakes
- Thinking the QP certifies only that the QC results pass.
- Assuming delegation of checks also transfers the QP's legal responsibility.
- Equating the QP with the US quality unit without noting the personal accountability.
The interviewer might ask next
How would a QP decide whether to certify a batch that had an unexpected deviation but met specification?