The role of a Qualified Person (QP) in pharmaceutical manufacture was introduced to European law almost 50 years ago. As new technologies, globalization, and even politics have changed the clinical landscape over time, QP responsibilities and legislation have evolved. Two recent changes, and what they mean for clinical trial sponsors, are summarized here.
First, since the United Kingdom completed its Brexit transition on December 31, 2020, QPs named on a UK manufacturing/importation authorization (MIA) license may no longer certify clinical trial batches of investigational medicinal products (IMPs) intended for EU trial sites. Sponsors need to make sure they have an EU-based site of importation and QP if receiving IMPs from the UK for EU trials. Additionally, sponsors with only an EU-based MIA holder and QP will need to enlist a UK MIA holder if they intend to manufacture and/or distribute IMP within the UK, as an EU QP certification alone would no longer be accepted. As before, QPs need to be listed on the MIA license for the site of batch release.
Second, as of January 1, 2022, the MHRA implemented a new QP oversight requirement in Great Britain regarding the importation of IMPs from an approved country (currently all EU and EEA Member States). This involves an extensive assurance system to ensure IMPs coming into Great Britain have been QP-certified before they left an approved country. While routine tasks in the verification process may be delegated to appropriate staff on the quality team, a QP named on the UK MIA license must oversee the process itself. With QP oversight of imports in place, IMPs do not require recertification, saving sponsors from additional costs and delays.
QPs are a crucial part of the clinical trial supply chain. Their certifications allow IMP to be released to clinical trial sites or depots. They ensure that batches of IMP are manufactured per specification, according to GMP standards, and in compliance with government regulations. Their work generally involves supply chain verification, production record review, and additional assessments to determine that a batch is compliant and safe for human use.
QPs have degrees in a scientific discipline, such as biology, chemistry, or pharmacy, along with practical GMP-manufacturing or pharmaceutical experience. They deeply understand the unique requirements of running clinical trials in the UK and EU.
Xerimis has a team of highly skilled QPs who can support your clinical trials in the UK and EU. Contact us to learn more.