No batch of medicine reaches a patient in the EU until one named individual takes personal legal responsibility for it. Understanding the Qualified Person’s role is fundamental to any manufacturing or import operation.
The Qualified Person (QP) is required by Directive 2001/83/EC, Articles 48 to 52, with the operational detail set out in Annex 16 of the EU GMP guide. The QP’s core duty is absolute: no batch may be released until the QP has certified that it was manufactured and tested in accordance with the marketing authorisation and EU GMP.
Certification versus confirmation
These two terms are often confused. Certification is the final act of batch release, where the QP takes full legal responsibility for the batch. Confirmation is a partial sign-off by a QP for a specific stage — manufacture or testing at another site — that feeds into the certifying QP’s decision. Only certification releases a batch.
Importing from third countries
Finished products imported from outside the EEA must, in principle, be fully re-tested within the EEA and certified by a QP — unless a Mutual Recognition Agreement or equivalent arrangement applies. This is a frequent point of failure for supply chains that assume third-country testing is sufficient.
The supply chain must be visible
Annex 16 requires the QP to have documented visibility of the entire supply chain of both the active substance and the finished product, right up to certification. A QP cannot certify what they cannot see.
The QP declaration for active substances
For marketing authorisation applications, the QP of the manufacturing or import site provides a written declaration that the active substance is manufactured to standards at least equivalent to EU GMP. It is a small document with significant weight.
How PQRA helps
PQRA advises on QP arrangements, batch release, importation testing strategy and the active-substance GMP declaration.
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