Glossary · GxP: good practices
Qualified Person (EU GMP)
Also known as: QP, EU QP, Qualified Person for batch certification
Under Directive 2001/83/EC, the Qualified Person (QP) is the person whom every holder of an EU manufacturing or import authorization must have permanently and continuously available, and who certifies each batch of a medicinal product before it is released for sale or supply. The QP confirms that the batch was manufactured and checked in accordance with EU GMP and its marketing authorization.
- GxP
- Pharma
- EU
In one sentence
The EU GMP Qualified Person certifies every batch of a medicinal product before release, under Articles 48–51 Directive 2001/83/EC and GMP Annex 16.
Example
Before a batch of vials imported from a third-country site is released in the EU, the importer's QP reviews the batch documentation, confirms EU testing was done and certifies the batch in the register kept for that purpose.
How it applies
- Legal role: Articles 48–51 of Directive 2001/83/EC set out the duty to have a QP, the minimum qualifications and experience, and the duty to certify batches. The QP is personally accountable and named in the manufacturing authorization.
- Batch certification: EU GMP Annex 16 describes how certification works, including batches manufactured in several sites or imported from outside the EU, and when a QP may rely on the checks of other QPs.
- Scope: The role applies to commercial medicinal products and to investigational medicinal products used in clinical trials.
- Technical documentation: The QP's decision depends on complete and reliable batch records, deviation and change records and the marketing authorization dossier. Gaps in these records, not the QP's signature, are what inspectors look for first.
EU GMP Qualified Person vs. machine-safety qualified person
The two terms only share a name. The EU GMP QP is a legally defined role for batch certification of medicinal products. The qualified person in machine safety is a worker with the training and experience to carry out certain tasks safely, such as electrical work. Neither can stand in for the other.
QP vs. PRRC
The PRRC under Article 15 MDR and IVDR is often compared to the QP, but the PRRC checks that device conformity, technical documentation and post-market duties are met; there is no batch-by-batch certification for medical devices.