A Guide to QP Certification of Investigational Medicinal Products (IMPs) for Clinical Trials

Streamline Your Clinical Trial Process with Expert QP Certification Support 

In the world of clinical trials, the successful launch of a drug or treatment is contingent on compliance with stringent regulations. For any Investigational Medicinal Product (IMP) intended for use in a clinical trial within the European Union, QP (Qualified Person) certification is essential. This critical certification ensures that the IMP complies with European regulations, such as Regulation (EU) No 536/2014, and is safe for patient use. In this guide, we will walk you through the QP certification process, why it is essential, and how BioBoston Consulting can support you every step of the way. 

 

Why is QP Certification Crucial for Clinical Trials? 

Ensuring Compliance and Safety 

The role of the Qualified Person (QP) in clinical trials cannot be overstated. A QP is legally responsible for certifying that each batch of IMP complies with all relevant regulatory requirements before it can be used in a clinical trial. This includes confirming that the IMP was manufactured in accordance with Good Manufacturing Practices (GMP) and that it meets safety, quality, and efficacy standards. 

For clinical trials conducted in the EU, only a QP residing within the European Union can carry out this certification. This means that ensuring you have a qualified, experienced QP is an essential part of your trial’s success. 

 

The Two-Step Certification Process: From Manufacturing to Clinical Use 

Navigating the IMP Certification Flow 

The QP certification process involves two main stages: the initial batch certification and the release for patient use. Here is how the process works: 

• Manufacturing or Importing the IMP: Once the IMP is manufactured or imported into the EU, the QP is responsible for reviewing all necessary documentation and performing the required checks to ensure compliance with EU regulations. 

• Certification and Release: After performing these checks, the QP certifies the batch of IMP, which triggers the green light for the sponsor to release the IMP for clinical trial use. 

Throughout this process, the QP ensures that the batch is compliant with regulatory standards and ready for patient administration. 

 

Key Requirements for IMP Certification 

What Does a QP Need to Ensure? 

Before certifying an IMP batch, a QP must ensure several key factors are in order: 

• Batch Records: The QP must review batch records, including in-process test reports, control reports, and release documentation. 

• Deviations: Any deviations from manufacturing protocols must be investigated and rectified. The QP will ensure that these deviations do not compromise the safety or quality of the product. 

• Stability and Validation Reports: The QP will ensure that stability data and validation reports for the manufacturing process, methods, and production facilities are in compliance. 

• Final Product Review: A QP examines the final product packaging and labeling to ensure it adheres to regulatory requirements. 

• Audit Reports: The QP reviews the manufacturer’s quality audits to verify GMP compliance. 

 

Manufacturing and Importing IMPs into the EU: What You Should Know 

Understanding EU Importation and Mutual Recognition Agreements 

Whether your IMP is manufactured within the EU or imported from a third country, QP certification is required for each batch before clinical trials can begin. The EU has Mutual Recognition Agreements (MRAs) with countries such as the USA, allowing IMPs manufactured abroad to be certified if they meet both EU and foreign GMP standards. 

However, it is important to note that MRAs do not cover all types of products, such as advanced therapy medicinal products or veterinary products. Knowing the specific regulatory requirements for your product is essential to avoiding costly delays. 

 

Speeding Up Your Clinical Trial with QP Certification 

Avoid Delays in Your Clinical Trial Process 

The timely certification of IMPs is vital for clinical trial success. Delays in certification can significantly slow down the entire process, which may extend timelines and increase costs. By working with a qualified QP and following the certification process carefully, you can streamline your trial, helping it move forward efficiently and stay within budget. 

Given that less than 10% of Phase I studies successfully reach the market, adhering to the certification process is key to improving your chances of success and reducing the risks associated with clinical trial delays. 

 

Let BioBoston Consulting Guide You Through the QP Certification Process 

Expert Support for EU Batch Certification 

At BioBoston Consulting, we specialize in supporting pharmaceutical and biotech companies through the complex world of clinical trial certification. Our team of regulatory experts can guide you through every step of the QP certification process, ensuring that your IMP batch complies with all European regulations and is released for clinical trial use without unnecessary delays. 

We understand the importance of adhering to timelines and minimizing regulatory hurdles. Let us help you navigate the certification process and bring your IMP to market efficiently. 

 

Contact BioBoston Consulting Today for Expert QP Certification Support 

Streamline Your Clinical Trials and Meet EU Regulations 

Need assistance with QP certification or preparing your IMP for the EU market? BioBoston Consulting offers expert guidance on regulatory compliance, batch certification, and clinical trials. Our team is here to ensure that your clinical trial is on track for success. 

Contact BioBoston Consulting today to learn how we can assist you with navigating the complexities of the QP certification process and ensuring timely approval for your clinical trials.