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Understanding the Role of Qualified Persons in Clinical Trial Supply Chains

  • PRONAV
  • May 13
  • 5 min read

When developing an investigational medicinal product (IMP), the journey from manufacturing to patient administration is complex and highly regulated, and for good reason: to protect patient safety. Therefore, ensuring IMPs meet stringent quality and safety standards before reaching clinical trial sites is a nonnegotiable step towards trial success. 


In Europe, Qualified Persons (QPs) play a central role in this process. EU and UK regulatory guidelines require that a QP certifies each batch before it can be used in a clinical trial (1,2). Their role is to ensure compliance with Good Manufacturing Practice (GMP), the Product Specification File (PSF) and the registered particulars thereby reducing risks of product contamination, mislabeling, or compromised integrity (3,4). 


For emerging biotech and pharma companies running clinical trials in the EU or the UK, understanding the roles and responsibilities of a QP is essential to ensuring a smooth clinical trial supply chain and preventing costly delays.


What Is a Qualified Person?


A QP is an independent, legally designated expert responsible for batch certification before the release of an IMP for use in clinical trials (5). This applies to all IMPs either manufactured in or imported into the EU or UK. The role of a QP is critical in maintaining compliance and preventing issues that could impact the quality or safety of each batch of an IMP (5). 


Unlike the EU and UK, the US does not require QP certification for batch release. However, IMPs used in US clinical trials must still adhere to GMP regulations and be certified through internal quality control processes (7). Moreover, if an IMP manufactured in the US is to be imported into the EU, batch certification by a QP is necessary. 


The Role of a Qualified Person in Clinical Trial Supply Chains


QPs perform multiple critical functions that help ensure compliance, quality, and patient safety: 


  1. Review of Supply Chain and Batch Manufacturing Data and Ensuring Compliance with GMP

A QP’s primary duty is ensuring compliance with GMP. This involves reviewing supply chain records, batch records, and quality control data to confirm that the drug manufacturing process and the materials used meet the required GMP standards(5). Additionally, QPs ensure that IMPs are produced according to the precise specifications registered in the Investigational Medicinal Product Dossier (IMPD) 8 and/or the Investigational New Drug (IND) submissions


  1. Batch Certification and Release

Before an IMP batch can be shipped to a trial site, it must be certified by a QP to confirm it meets the appropriate quality, safety, and efficacy requirements. Without QP approval, an IMP batch cannot be used in any EU or UK trial. Ultimately, this protects patients by ensuring that unsafe drugs are not administered to trial participants (6). 


  1. Quality Audits

QPs are responsible for conducting audits of manufacturers, testing labs, and distribution facilities to ensure compliance with GMP and other regulations, thereby reducing the risk of compliance issues disrupting the trial process.


Key elements of QP audits include assessing the effectiveness of quality management systems, scrutinizing documentation and record-keeping processes, examining vendor qualification processes, and verifying the competency of personnel involved in the manufacturing process.


  1. Risk Assessment

All of the above means that QPs play an important role in risk assessment by identifying potential issues that could occur, thereby preventing costly delays due to compliance issues or product recalls and ensuring trial timelines are met (9). 


Best Practices for Working With a QP

Given the crucial role of a QP in clinical trial supply chains, it’s important for sponsors to understand how best to work with a QP to maximize their value and give the trial the best possible chance of success. 


Early Engagement

Companies should engage QPs early in the process to minimize the risk of delays later down the line. Waiting until the batch release stage to involve a QP increases the risk of compliance issues and delays. Instead, bringing a QP in during the planning, manufacturing, and packaging stages ensures that all the necessary quality control measures are in place from the get-go. Early engagement also allows companies to integrate QP oversight into their broader clinical supply strategy, ensuring that compliance is considered at every stage of the supply chain. 


Robust Documentation

QPs rely on documentation, including batch records, manufacturing reports, and stability data, to approve a batch for clinical use. Missing or inconsistent documentation can slow down the approval process significantly, leading to unnecessary delays in batch release. 


It is vital that a comprehensive and clear picture of all product and associated quality/regulatory information flows are identified from the outset. For instance, failing to include a key third party release testing laboratory in the QP Declaration of GMP Compliance during a Clinical Trial Application submission can result in significant project delays and financial costs.



PROMAP Workflow Map
PROMAP Workflow Map


Having identified all of the data sources it is then essential to compile the information in a structured manner that is easily accessible to all of the parties involved. Implementing a centralized task and document management system, such as PROMAP, can streamline this process and ultimately provide real-time visibility for QPs and support efficient batch certification (10,11). 



PROMAP Documentation Management
PROMAP Documentation Management


Choose Partners Carefully

One of the key responsibilities of a QP is auditing vendors to ensure quality and compliance. Therefore, selecting trusted partners with a proven track record is essential to preventing problems and delays. Working with experts who understand and can advise on regulatory requirements and clinical trial supply chain operations is pivotal in ensuring that batch certification (and the rest of the clinical trial supply chain) runs smoothly. 


Conclusion


QPs are essential for ensuring that IMPs meet regulatory and quality standards before reaching trial sites. Their roles in batch certification, vendor auditing, and GMP compliance prevent costly disruptions, ensure trial integrity, and, ultimately, protect patient safety. 


For pharma and biotech companies, engaging a QP is not only essential to meet legal requirements, but it is also key to trial success. By engaging an experienced QP and integrating their oversight into regulatory compliance and supply chain operations, companies can minimize risks and ensure trials proceed without unnecessary and costly delays. 


Looking for expertise to streamline your clinical trial supply chain? Get in touch with PRONAV Clinical today to learn how we can help your team achieve clinical trial success!


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