The Qualified Person (QP) is a legally designated responsible person in the EU who ensures the release of medicinal product batches for placing on the market. They confirm that each batch has been manufactured and tested in accordance with EU GMP requirements and that the batch documentation is complete and compliant. For pharmaceutical companies, manufacturers, contract manufacturers and also for sponsors of clinical trials, the QP is a central compliance function, because in many cases lawful release is not possible without QP certification.
In the clinical setting, a distinction is often made between the QP function for authorised medicinal products and the release of investigational medicinal products. In both cases, responsibility for quality, traceability and compliance with regulatory requirements is paramount. For CROs, this topic is relevant because supply chains, import/export, labelling and record-keeping in trial logistics projects frequently contain QP-relevant interfaces.
Tasks and responsibilities of the Qualified Person
The QP ensures that each batch has been manufactured and tested in accordance with EU GMP requirements. This includes reviewing the manufacturing and testing documentation, assessing deviations and CAPAs, and confirming that batch specifications are met. The QP must be able to exercise independent judgement and bears a personal responsibility that, in practice, requires a high degree of diligence in documentation and change control.
Typical areas of focus include the assessment of critical process steps, ensuring data integrity, handling OOS/OOT results, supplier qualification, and release following changes (e.g. process or site changes). In global supply chains, the QP must also assess whether external manufacturers meet equivalent standards or what additional evidence is required.
QP in the context of investigational medicinal products (IMPs)
Special requirements apply to investigational medicinal products, particularly regarding labelling, randomisation/blinding and traceability. QP release of IMPs often includes, in addition to GMP aspects, a check of whether the product is consistent with the approved clinical study protocol and the regulatory submissions. For imports from third countries, QP certification is regularly required in the EU after manufacture and, where applicable, additional testing. This makes the QP a central interface between manufacturing, quality control, the clinical supply chain and Regulatory Affairs.
In practice, challenges arise from short-notice protocol amendments, multilingual labelling and coordination between depots and investigational sites. A common error is addressing changes to labels or packaging too late, which jeopardises release timelines and trial milestones. Robust supply and change management reduces these risks.
Qualification, appointment and organisational integration
The qualification requirements for a QP are set out in EU law and national implementing provisions. As a rule, a relevant scientific degree and practical experience in pharmaceutical quality assurance and manufacturing are required. Formal appointment is made by the company; competent authorities may assess the suitability and integration of the QP as part of inspections.
Organisationally, the QP should be positioned such that they can make independent decisions, even where this results in short-term commercial disadvantages (e.g. withholding a batch). Audits frequently examine whether the QP has appropriate access to information, training and resources, and whether responsibilities are clearly defined.
QP certification, documentation and regulatory interfaces
The QP typically documents release via a formal certificate or release statement. Traceability is central: audit trails, controlled documents, verified specifications and clean deviation handling are prerequisites for a legally sound decision. Data integrity encompasses not only laboratory values but also production data, logbooks, electronic systems and interfaces with suppliers.
In inspection practice, QP decisions are often assessed retrospectively: were deviations appropriately assessed? Are the risk assessments traceable? In the case of critical findings, was a batch rightly withheld or released? A robust chain of justification is therefore essential. At the same time, interfaces exist with further regulatory requirements: for clinical trials, requirements under the EU CTR 536/2014 (e.g. on IMP handling and documentation) are relevant, among others; for authorised medicinal products, marketing authorisation dossiers and approved manufacturing processes play a role. For the sponsor and CRO, it is helpful to integrate QP review into timelines, contracts, labelling processes and change control at an early stage.
In practice, it is beneficial to involve the QP in project milestones at an early stage: defining “release gates”, specifying the documents required per batch, and clear escalation pathways for deviations. Particularly in the case of short-notice changes (e.g. label updates, new depots, amended testing schemes), early QP involvement determines whether delivery dates can be met without incurring compliance risks.
FAQ
Is a Qualified Person only relevant for authorised medicinal products?
No. QP release may also be required for investigational medicinal products, particularly for imports, for manufacturing steps carried out in the EU, and where regulatory requirements demand formal batch certification.
What risks arise if QP processes are not properly integrated?
Typical risks include delays in batch release, non-compliant labelling, incomplete batch documentation, or unresolved responsibilities in the event of deviations. These risks can jeopardise both trial milestones and compliance.
How does the QP work with the CRO and sponsor?
The QP usually operates on the manufacturer’s or contract manufacturer’s side but relies on information from the clinical supply chain, Regulatory Affairs and quality management. Clear communication channels and shared change control avoid late surprises and accelerate releases.
Regulatory references (selection)
- EU GMP Guide, in particular the chapters on batch release and responsibilities
- Directive 2001/83/EC (Community code relating to medicinal products for human use) – legal basis of the QP function
- Regulation (EU) No 536/2014 (Clinical Trials Regulation) – relevant interfaces for IMPs