EU & UK QP Release
QP Release: the seal of approval
QP Release is a critical stage in clinical trials: it is the process whereby Qualified Persons (QPs) ensure that a batch of investigative medicinal products (IMPs) that has been manufactured are of a high enough quality that they can be released for use in clinical trials.
Qualified Persons (QP) play a critical role in bringing safe, timely products to the market, and must be aware of the complex interplay of regulations and environment in their destination country.
QP releases ensure that batches are released with the appropriate communications, data and regulations for their destination country. To ensure application of their expertise, and to remain up to date with relevant legislative changes, QPs typically oversee projects according to their field of expertise.
QPs have personal and legal responsibility as defined by the EU Clinical Trial Directive (2001/20/EC), and typically, QPs are accountable from manufacture all the way to the end-user, by:
- assessing GMP issues across the supply chain
- participating in inspections and audits at sites involved in the manufacturing and distribution of IMPs
- being a reliable contact for the health authorities
- applying relevant legislation and processes, including exceptions which may impact the quality and safety of the IMP
- being involved in complaint handling and recall processes
At Eramol, our QPs are qualified for UK and EU batch release and are actively involved within the Project Management team throughout the product life cycle. Eramol also utilises the same QP release process for territories outside of the EU and UK.
QP Auditing
All Eramol QPs are IRCA-trained lead auditors with extensive global experience in auditing the following product types and areas
Seamless transition
The release of IMP products into use for clinical trials demands a seamless release, which means a joined-up service from project setup to batch certification, right through the supply chain, and finally on to the end user.
Rest of World Release
As we are a UK-based operation, any concerns about the effect of Brexit are mitigated thanks to our sister QP batch release site in Ireland (part of the EU). The two sites are fully integrated to enable a smooth, hassle-free solution for EU and UK IMP supply chains.
QP Support
Eramol QPs have a wide range of knowledge and experience to provide expert regulatory and CMC (chemistry, manufacturing and controls) advice to clients planning clinical trials.