To further improve the GMP services the CBC can provide for it’s academic sponsors, the CBC has been granted an extension of its manufacturer’s authorisation by the MHRA, to cover the importation of recombinant proteins and gene therapy vectors as investigational medicinal products from outside the EU.

This includes:

• Qualified Person audit and certification of EU cGMP compliance by the manufacturing site.
• Qualified Person batch sign off and release of imported material
• Incoming inspection and quality control
• Controlled temperature storage.
• Re-packaging, if required.
• Issue to clinical trials site

Back to CBC Homepage