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:
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.
All Eramol QPs are IRCA-trained lead auditors with extensive global experience in auditing the following product types and areas
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.
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.
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.