A Roadmap for Clinical Trials: QP Certification of IMP

The Role of Qualified Persons (QPs) in Clinical Trials: A Key Step for Successful EU Batch Certification 

In the 20th century, scientific advancements in medicine dramatically reshaped the healthcare landscape, with clinical trials playing a pivotal role. Whether you are introducing innovative medicines or conducting bioequivalence studies for generics, clinical trials are essential for the development, approval, and lifecycle management of drugs. Before any Investigational Medicinal Product (IMP) can be used in a clinical trial, it must be certified by a Qualified Person (QP) to ensure compliance with strict European Union regulations. In this blog, we delve into the process of QP certification and its critical role in getting your IMP to market quickly and efficiently. 

Why Is a Qualified Person Essential for Clinical Trials? 

A QP is required for the certification of each batch of IMPs intended for clinical trials. This applies to any medicinal product manufactured or imported into the European Union for human use. A QP ensures that the IMP adheres to all regulatory requirements before being released for patient use in clinical trials. Only a QP residing in the EU is authorized to perform this certification. 

Different EU member states have specific requirements for QPs, including qualifications, experience, and language proficiency. A QP not only verifies compliance with regulatory standards but also helps to prevent delays that could jeopardize your clinical trials timeline. 

The Certification Process: From Manufacture to Patient Administration 

Once an IMP is manufactured or imported, it is under the sponsor’s control until it undergoes a two-step certification process. First, the QP certifies the IMP batch, ensuring that it complies with all relevant standards, including those outlined in Regulation (EU) No 536/2014. After certification, the sponsor releases the IMP for use in the clinical trial, completing the regulatory “green light” process. 

The QP is tasked with confirming that all the conditions for batch release are met, including compliance with the Clinical Trial Directive (2001/20/EC) and other applicable regulations. Only after this certification can the IMP be administered to clinical trial patients. 

What Does a QP Need to Certify an IMP? 

A QP ensures that several elements are in order before batch certification can occur. These elements include: 

• Batch records: The QP reviews documentation such as control reports, in-process test reports, and release reports to ensure compliance with product specifications. 

• Deviations: Any manufacturing deviations or planned changes must be assessed, investigated, and rectified. If a deviation impacts the quality, safety, or efficacy of the product, the QP may delay certification until all issues are addressed. 

• Stability and validation reports: The QP ensures that the stability of the IMP and the validity of the production facilities, processes, and methods are verified. 

• Finished product examination: The QP examines the final product packaging and ensures that it aligns with regulatory requirements. 

• Audit reports: The QP reviews quality system audit reports from the manufacturer to ensure that they comply with Good Manufacturing Practice (GMP) standards. 

Manufacturing and Importing IMPs into the EU: What You Need to Know 

Whether an IMP is manufactured within the EU, imported from a third country, or sourced from the open market, QP certification is required for every batch. The European Union has entered into Mutual Recognition Agreements (MRAs) with third-country authorities, allowing for batch certification of products that comply with both EU and foreign GMP standards. These agreements streamline the process for products manufactured in countries like the USA, provided that the necessary GMP controls have been performed. 

However, the MRA does not cover all products. For instance, advanced therapy medicinal products, human blood and plasma, and veterinary products are excluded. The certification requirements must be thoroughly understood to avoid costly delays in the clinical trial process. 

The Importance of QP Certification for Speeding Up Your Clinical Trial Process 

In the clinical trial landscape, timely execution is paramount. Delays in the batch release process can slow down research and regulatory approval, adding significant costs. With fewer than 10% of Phase I studies successfully reaching the market, understanding the full certification process—and the role of the QP—becomes crucial. 

By following regulatory requirements and ensuring proper certification, you can streamline your clinical trial and avoid costly mistakes. BioBoston Consulting ‘s expertise can guide you through every step of the QP certification and IMP release process, ensuring that you meet all European regulatory standards and keep your trial on track. 

Get the Support You Need for EU Batch Certification 

At BioBoston Consulting, we understand the complexities of clinical trial certification and can help you navigate the European regulatory landscape with ease. From IMP batch certification to the final release for clinical trials, our experts are here to ensure that your product stays on track for timely approval and market launch. 

Contact BioBoston Consulting Today
Need assistance with QP certification or preparing your IMP for the EU market? BioBoston Consulting offers expert guidance on regulatory compliance and clinical trials. Reach out to our team of professionals today to learn how we can support you in navigating the complexities of EU batch release and ensuring your clinical trial success.