In the EU, Investigational Medicinal Products (IMPs) cannot be released to clinical trial sites until the batch has been certified by a Qualified Person (QP). There are various different types of batch release depending on where the product has been manufactured.
Our QPs understand the unique requirements of running a clinical trial in the EU and work proactively with our clients to ensure all documents and audits are completed well in advance of supplies being needed at the trial sites.
Two-step release procedure
Step 1: QP named on an EU competent authority issued manufacturing licence confirms that the batch of IMP has been manufactured in compliance with EU GMP, the Clinical Trial Authorisation (CTA) and the Product Specification File (PSF).
Step 2: Essential regulatory documentation has been collected from the trial site. The minimum requirement for site documentation is Ethics Committee approval/favourable opinion and Regulatory Authority approval.
The QPs named on Xerimis’ license take personal responsibility for the quality of the IMP being released and provide certification that IMP batches comply with both EU GMP and the information submitted to EU competent authorities.
Xerimis QPs offer the following services:
- Site audit of manufacturing sites and testing laboratories
- QP Declaration for products manufactured outside the EEA
- Review of the study protocol and IMPD
- Checking the compliance of label text against Annex 13 requirements
- Weekly/biweekly conference calls with clients
- QP certification of the finishes supplies