They are characterized by their ability to repair, regenerate or replace human tissue or cells and can be used to treat a wide range of medical conditions, including genetic disorders, autoimmune diseases, and cancer. ATMPs include gene therapies, cell therapies and tissue-engineered products.
Due to the complex nature of ATMP manufacturing, quality assurance (QA) and regulatory compliance are of utmost importance to ensure the safety, efficacy, and consistency of these products. This is where Qualified Person (QP) services come into play. QP services are essential for ensuring that the manufacturing process of ATMPs complies with the Good Manufacturing Practice (GMP) guidelines set by regulatory agencies. The evolving role of a QP in the certification of an ATMP.
The role of a Qualified Person (QP) is critical in the certification of an Advanced Therapy Medicinal Product (ATMP). The QP is responsible for ensuring that the ATMP is manufactured, tested and released in accordance with the applicable regulations and guidelines and that it is safe and effective for its intended use.
The QP is an independent expert who certifies that each batch of an ATMP has been produced and tested in compliance with the relevant regulations, guidelines and manufacturing requirements. This certification confirms that the batch is safe for use in patients and that it meets the necessary quality standards.
The QP must review all the manufacturing, quality control and quality assurance documentation related to the batch, including batch records, test results and stability data, to ensure that the product meets the required specifications. The QP must also verify that the manufacturing process, equipment and facilities used to produce the ATMP are validated and meet the necessary standards.
ATMP regulation
As the field of ATMPs continues to evolve, the QP's role is becoming even more important. This is because ATMPs are highly complex to manufacture and require specialized knowledge and expertise. Additionally, the regulations and guidelines for ATMPs are constantly changing and evolving, which requires the QP to stay up-to-date with the latest developments.
Bram Keymolen, co-founder and QP at eyetec, was one of the first QP’s in Belgium involved in ATMP manufacturing under GMP. In this pioneering role, thanks to a close collaboration with Federal Agency for Medicines and Health Products (FAMHP), he managed to set a framework for the manufacturing of ATMPs under GMP, based on an interpretation of existing GMP regulations. With extensive experience in clinical research institutes involved in the production of ATMPs, such as the University Hospitals of Antwerp, Brussels and Ghent, eyetec possesses a deep understanding of the implications of this framework and the intricacies of ATMP manufacturing. This expertise enables them to provide valuable guidance on the appropriate implementation.
In need of a QP?
When you reach out to us for QP services in the ATMP field, expect comprehensive support tailored to the unique challenges of this innovative landscape. With a team deeply rooted in regulatory compliance and possessing in-depth knowledge of clinical research nuances, we offer more than just QP services – we provide a collaborative approach to navigating the dynamic world of ATMP manufacturing.
