Good Manufacturing Practice (GMP) Suite
Quality Assurance Manager: Bertie Craig BSc
The Institute hosts Newcastle Biomedicine’s core state of the art clean room facility as part of the North East of England Stem Cell Institute (NESCI). The facility will primarily be used for research and development of stem cell based therapies; though other cell based work can be accommodated. The facility is licensed by the HTA under the Human Application (Quality & Safety Regulations), which allows it to be used in preparing clinical material.
There are a total of 9 ‘Grade B’ laboratories (as defined by the MHRA), 5 in the “E” suite and 4 in the “S” suite. The laboratories in both suites are equipped with Class II microbiological safety cabinets to provide ‘Grade A’ working environments housed in the ‘Grade B’ atmosphere. Storage facilities are provided by both vapour phase liquid nitrogen and -80oC incubators.
The suite is operated to the exacting standards required of current Good Manufacturing Practice. The management of the facility is led by the QA Manager, with support of a dedicated QC technician; both of whom have come to the Institute from an industrial background.For further information
please see www.nesci.ac.uk or contact: Bertie
Craig.
