Development Programme:
January to June 2004
The building work on the GMP facility was completed by late December 2003.
In preparation for the monitoring and testing programmes the facility underwent
a comprehensive 8-stage clean-down which was intended to reduce particles and
micro-organisms to a level consistent with a pharmaceutical-type facility.
Once this was completed in early January, work on validating the facility,
its systems and equipment began. The first phase of this initially involved the
Facility Qualification (FQ) which entailed confirming that the fabric of the building,
the electrical and telemetry systems and the drawings and schematics could be shown
to accurately reflect design specifications. Installation Qualification (IQ) was
conducted on each item of equipment and reflected a similar process to the FQ.
All IQs for essential equipment were completed in February and the consultants,
together with members of the Bank’s staff began the process of Operation
Qualification (testing that the equipment functioned according to its design specification).
This involved testing alarms, measuring temperature, assessing accuracy of monitoring
systems etc. Performance Qualification (measuring the performance of the equipment
against the UKSCB specification in a simulated working situation) followed.
In tandem with this process, the UKSCB quality system was readied for inspection by the UK Medicines and Healthcare Products Regulatory Authority (MHRA). This is the UK body that inspects and accredits all UK Tissue Banks supplying cells and Tissues for therapeutic use within the NHS. Inspection is against a Department of Health (DH) Code of Practice for Tissue Bankwhich is modelled on current EU Pharmaceutical GMP and also the NBS guidance on best practice. This code of Practice covers all aspects of the collection, processing and supply of tissue and cells including the facilities in which the work is carried out.
The potential uses to which both research and clinical grade stem cell lines maybe put in the future have necessitated a rigorous and diverse quality system. This involves elements from a number of international standards as well as GMP and has been designed to comply with the DH Code of Practice for Tissue Banks and the Steering Committee’s Code of Practice for the UKSCB and the Code of Practice for The Use of Stem Cell Lines. As well as complying with these Codes of Practice, the system incorporates NIBSC procedures which comply with ISO 17025 (Governing testing procedures) and ISO 13485 (for in vitro diagnostics). Additionally many management activities are modelled on the requirements for ISO 9000:2000. The quality system is a hierarchical system of linked documents covering all aspects of the Bank’s activities from supplier agreements through cell processing, safety testing, characterisation and quality control to the release of cells for issue. It also links to validation documentation to provide elements on operation, maintenance and training in the use of the validated equipment. During preparation of the Bank for inspection, over 350 separate documents (Component Specifications, Standard Operating Procedures, Forms, etc) have been written in addition to a comprehensive Quality Manual which details the overall strategy delivering compliance with the Codes of Practice.
The Bank underwent its first internal audit in March prior to its inspection by the MHRA in April. This was carried out by the NIBSC quality department in conjunction with consultants from Jacobs Engineering and highlighted a number of areas which the Bank was able to address prior to the MHRA inspection. The MHRA inspection was carried out at the beginning of April. No critical non-compliances were issued and the accreditation of the Bank under the DH Code of Practice appeared to have been successful, subject to a satisfactory response to the non-compliances (one Major and number of Minor) issued by the MHRA. These were addressed by the Bank in May in its response to the MHRA inspection letter and a certificate of accreditation was issued in Mid-June.
Following its successful inspection, the Bank was officially opened on 19th May 2004 by Lord Warner, Undersecretary of State for Health. This coincided with the permission from the Steering Committee for the Bank to take in (Accession) the first two UK stem cell lines developed at King’s College, London and at the Centre for Life at Newcastle University. Over the next few months the Bank will be working closely with the depositors to translate the cells from the research environment into the Bank where they will undergo a comprehensive safety testing, cell characterisation and quality control regime prior to being made available to the scientific community.