Understanding the essential role of Qualified Persons in clinical trials
Patient safety is paramount in clinical trials, just as it is in commercial pharmaceuticals. Qualified Persons (QPs) in the EU and UK play a vital role in certifying pharmaceutical products before use, ensuring compliance and quality of investigative medicinal products (IMPs).
As part of running a trial in the EU or UK, sponsors manufacturing IMP outside the EU or UK must submit a QP declaration to ensure batches have been manufactured to Good Manufacturing Practice (GMP) equivalent to EU GMP. To provide this declaration, QPs must review evidence such as audit reports.
Beyond declarations, QPs certify each IMP batch before release. The certification involves reviewing extensive documentation, typically categorized into three areas: regulatory documents (IMPD, study protocol, regulatory approvals), supply chain records (QP declaration, quality agreements), and batch-specific records (manufacturing data, in-process controls). Additional documents include stability data, blinding checks, and label text. Once all documentation is verified and no quality, safety, or compliance risks are found, the batch is certified for use in clinical trials.
Legal responsibility and accountability
QPs carry personal legal responsibility for the products they certify and release. If a defective batch is knowingly approved and harms a patient, the QP is held personally liable—unlike in the US, where quality representatives exist but do not bear legal accountability. In such cases, the company, not the individual, would be responsible.
QPs operate with full authority, and their decisions cannot be overruled by management. Given the high stakes, they must stay ahead of evolving technologies and regulatory updates. Continuous internal and external training, along with on-site audits, ensures QPs maintain the expertise needed to uphold the highest quality and safety standards in pharmaceutical manufacturing.
Navigating UK/EU QP certification challenges
The UK’s withdrawal from the EU in 2020 brought significant changes to the QP certification landscape. UK QP certifications are no longer valid in the EU, requiring all batches to be recertified by an EU QP. However, an EU QP can still certify batches for the UK market if a UK QP provides oversight.
With seamlessly integrated facilities in both the EU and UK, Thermo Fisher Scientific simplifies this process for our customers. Our QPs have real-time visibility into all documentation, ensuring a smooth certification process without unnecessary delays or complexity. This flexibility allows biotechs to efficiently serve both markets while maintaining compliance and operational efficiency.
Building strong QP partnerships
QP certification is a critical component of the clinical trial supply chain, often outsourced to experts like Thermo Fisher Scientific. Successful partnerships depend on biotechs treating QP services as an integral part of their operations. Open communication and timely documentation ensure investigational products reach patients on schedule—safely and in full compliance with regulatory standards.
