Our well-established QP services help to streamline your product’s journey from clinical trial to market release in the EU and UK, giving you the confidence that your investigational or commercial drug product have been processed and released in compliance with local GMP regulations.
Our QP services for both investigational and commercial drug products help you meet the unique and complex regulatory demands of the EU and UK.
To be able to import and/or distribute medicinal products into the EU or the UK, our facilities, located in the EU or the UK, hold valid Manufacturing and Import Authorization (MIA) licenses and have QPs available, which are responsible for the release of each batch of IMP for usage in clinical trials or for commercial distribution within the EU.
What is the role of the QP?
It is the QP’s responsibility that medicinal products entering the EU market have been processed following the principles of good manufacturing practice (GMP) and the product has been manufactured in accordance with the Marketing Authorisation. QPs need to demonstrate relevant experience, especially because they accept personal and legal responsibility as defined by European Legislation. For batch release, QPs need to have full access to the relevant parts of the registration file and knowledge of the supply chain. Regular audits at suppliers in the supply chain are performed to ensure the QP that manufacturing has been performed in accordance too GMP and the marketing authorization. After a review of the documents related to the manufactured batch, a release certificate will be issued by the QP and allow you to distribute the released batch for usage in clinical trials or the commercial market.
We can then work with you to manage the storage and distribution of your products.
“Batch release to market is often seen as the very end of the manufacturing process, but in reality, it begins much earlier than that. Fully establishing the upstream release process means QP certification can be awarded with much greater degree of confidence”.
Ria Rhemrev-Boom, QP.
Qualified Person and Regulatory Services for Clinical and Commercial batches (EU/UK)
- Supply chain auditing
- Auditing to GMP/GLP/PICs
- Production of QP 3rd party declarations
- Batch certification of IMP
- Batch approval and release
- Issuing Certificated of Release to allow EU and/or UK distribution of authorized drugs
- QP GMP certification of IMP undertaken by Sharp
- QP GMP certification of Active Substance for registration
- IMPD support (simplified, full, compliance review)
- Regulatory advice support
- Consultation with a QP
- UK QP oversight process (import from the EU 1. Jan. 2022 onwards)
Quality infrastructure
- QualityOne QMS
UK QP Oversight Process
Sharp can support you in overcoming the additional complexity when importing your finished clinical trial material from the EU to the UK. From 1 January 2022 onwards, importing Investigational Medicinal Products (IMP) from countries on a list (EAA and EU countries) to Great Britain will require a QP Oversight process.
There are different routes for IMPs to be received into Great Britain following QP certification by the listed country MIA(IMP) holder:
– Direct to the Great Britain clinical trial site
– Via a Great Britain storage and distribution ‘hub’
Sharp and our QPs are ready to support both models and we are happy to discuss the options and what is needed to assure a smooth process from the EU to the UK.
Whether for commercial release or your clinical trial, talk to our expert team today about your QP release needs.
