Ilika plc is pleased to announce that Altrika Ltd, its wholly owned subsidiary, hosted the first joint inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA). The MHRA and HTA approached Altrika as an ideal organization to initiate their new inspection approach to establishments whose activities fall under both of their remits. Altrika’s facilities in Sheffield, which have been licensed by the HTA since 2006 and MHRA since 2008, produce skin cell treatments for severe burns (Cryoskin® and Myskin®). Both these products share a common production platform, but as only one is classified as medicinal they are separately regulated.
Following the successful inspection outcome, Altrika has been invited to contribute to the HTA’s Annual Report and Annual Review event in June.
“We are very pleased to have been selected to act as the first joint inspection candidate and work with the regulators to help make the inspection process more efficient” said Graeme Purdy, Altrika CEO. “It is testament to the skills and dedication of our staff, and the standard of our facilities that this joint inspection has gone so well and it demonstrates our commitment to the quality of our operations.”
Cryoskin®, using Altrika’s in-house GMP donor keratinocyte cell bank, is supplied under a Manufacturer’s Specials Licence from the MHRA, whilst the provision of Myskin®, using the patient’s own cells, is currently regulated by the HTA. Both products are available in the UK and undergoing pan-European approval.
For further details, please contact:
Tel. +44 (0) 23 8011 1400
Graeme Purdy, Chief Executive
Steve Boydell, Finance Director
Pelham Bell Pottinger
Tel. +44 (0) 20 7337 1509