GMP

All medicines that are being investigated as part of a clinical trial are expected to meet good manufacturing practice standards (GMP).  

The University of Manchester has in the past held three manufacturing licenses.  Currently, it does not have any GMP licensed facilities.  However, we have extensive experience in working with manufacturing organisations to source medicinal products (advanced therapies to re-purposing licensed medicines.

In addition if you are working on medical devices the standard to which a product has to be manufactured - this includes software as well as hardware - is defined in ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes.  Please note that there may also be other standards that may apply.

If you require information and or advice about manufacturing medicines for use in trials, please contact us at clinicaltrials@manchester.ac.uk.

If you require information and or advice about manufacturing medical devices for use in trials, please contact us at medicaldevices@manchester.ac.uk.