Qualified Person (QP) and QA services
Ensuring compliance, patient safety and efficient trial execution
Qualified Person (QP) release is mandatory for any drug product intended for use in clinical trials in the EU. QPs are responsible for certifying that every batch released for use in humans meets EU regulatory standards and is consistent with the approved trial authorization. At KLIFO, our highly experienced QP team provides the expertise, oversight and flexibility needed to keep your clinical programs compliant and on track.
What a Qualified Person does
The QP role is defined under EU law and is central to pharmaceutical quality assurance. A QP must review and certify that every product batch is safe, manufactured under Good Manufacturing Practice (GMP), and used only as authorized.
Key responsibilities include:
- Certifying batch release for use in EU clinical trials
- Reviewing compliance with EU GMP and trial authorization requirements
- Ensuring quality of investigational medicinal products (IMPs) and comparators
- Overseeing documentation, audits and supplier qualification
- Supporting risk management and data integrity across the supply chain
This legal responsibility makes the QP a cornerstone of regulatory compliance, product safety and patient protection.
Why QP services matter in clinical trials
For sponsors, delays in QP release can have a significant impact on clinical trial timelines if their trial includes EU countries. Drug cannot be shipped to clinical sites until it has been released by a QP, so EU . Problems often arise when:
- Critical documentation is incomplete or unavailable at the time of release
- Upstream ex-EU manufacturing sites have not been audited according to EU standards, preventing a QP from releasing products
- Sponsors outside the EU are unfamiliar with QP requirements, so have not allowed sufficient time in their clinical plans to allow for establishment of a robust release process
- Limited QP resources create bottlenecks and delays in clinical study timelines
With the right support, these risks can be eliminated. KLIFO ensures QP involvement is planned from the start and processes and requirements clearly defined in advance, enabling and timely product release and trial execution.
Deliverables from KLIFO QP services
When working with KLIFO, clients receive clear, tangible outcomes:
- QP Release (Batch Certification)
- Product Specification File
- (Quality) Technical Agreements
- Audit reports and supplier assessments
These deliverables ensure compliance with EU directives and provide transparency for all stakeholders in the supply chain.
Guidance through every phase
It is never too early to employ KLIFO QPs in helping plan for EU clinical trials. Our QPs are experienced in guiding clients through the requirements for smooth QP release processes, identifying gaps in current processes and most importantly helping to close these. It is not unusual for preclinical clients to involve KLIFO QPs in designing quality systems long before they plan on entering the clinic. As candidates progress through clinical development, supply chains can change. KLIFO’s QPs are familiar with helping clients manage these change, ensuring that supply chains remain compliant as they scale up, and scale out, through the clinical development process.
Who benefits from KLIFO’s QP services
Our services are designed for:
- EU biotech and pharmaceutical companies needing additional QP support
- Non-EU sponsors planning clinical trials in Europe
- CROs and smaller CTS providers without in-house QP capacity.
QP release is required at every phase of clinical development. Whether supporting a first-in-human study or large-scale Phase III program, KLIFO ensures your supply chain is compliant and trial-ready.
Does KLIFO employ QPs or are these all contractors?
All QPs are KLIFO employees. In addition to our QPs, Danish regulations also allow our QPs to delegate some of their activities to suitably qualified members of the QA team. This effectively gives us a team of 6 staff able to perform QP duties. Based on the size of our company, this is significant and ensures that availability of QP resource does not become a bottleneck in the clinical supply chain.
Is it necessary for QPs to personally audit all ex-EU facilities in our supply chain?
KLIFO QPs take a pragmatic view of these, and provided audits were performed recently and by suitably qualified auditors, KLIFO will accept reports from audits conducted by others. As a result, audits may not need to be repeated, resulting in faster start-up times and reduced costs for our clients.
How do we know what information and documentation we need to provide to KLIFO in support of QP release?
A full list of QP requirements is included in our Work Order, which is issued for every project. We are happy to provide clients with a full list ahead of this if required.
Actual requirements will vary based on the supply chain (e.g. EU vs ex-EU manufacturing sites) for the investigational product, and whether our QP if providing final batch certification or is just certifying activities performed by KLIFO, with another QP (e.g. client QP) performing final batch certification.
