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Safety and quality


We work within a highly regulated environment and operate under a quality system

You’re in safe hands

Quality and safety are synonymous within Tissue and Eye Services. A quality graft is a safe graft and patient safety is our paramount concern. Our system ensures traceability of tissues from donor to recipient hospital and the highest standards of microbiology testing.

Our safety and quality processes

Regulatory compliance

We were amongst the first tissue banks in the UK to be inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA). This has been superseded by the Human Tissue Act, and Tissue and Eye Services is licensed by the Human Tissue Authority (HTA). All our procedures comply with:

Good Manufacturing Practice (GMP)

All tissue donor selection and tissue retrieval, processing, storage and issue activities are controlled via the principles of GMP. This includes the control of processes, documents, personnel, change, facilities, consumables and the management of adverse events and incidents.

Independent Quality assurance (QA) release

All tissue batch records are checked by a Tissue Bank Manager and an independent Quality Assurance Manager. Tissue release is controlled by the PULSE computer system which checks that all mandatory results are acceptable before enabling the transfer of tissue from quarantine to available for issue.

Ongoing training

Our team undergo rigorous, detailed training programmes and are assessed to ensure they are competent prior to undertaking their duties.

Safe new product development

Processes are validated to ensure they are effective prior to the implementation or introduction of a novel processing method or tissue. Any change to a process is also validated and has to be controlled via the change control process. New tissue grafts are validated and introduced via the GMP Tissue Validation and Development Laboratory and the Technology Centre.

Traceability

Tissue is traced from donor to final product via bar code labelling to the ISBT 128 system. This ensures anonymity for the donor whilst maintaining links to all testing and processing records. All equipment and consumables used in tissue donation and processing are recorded. 

State of the art tissue BANK

The Tissue Bank was designed and purpose built in collaboration with experts to ensure compliance with GMP. This world class facility has a suite of clean rooms to ensure all products are processed to the highest possible quality standards.

Continuous improvement

The Tissue Bank is audited regularly by NHS Blood and Transplant's team of expert independent auditors. This ensures continued compliance and also drives continuous improvement. 

Multidisciplinary team

All aspects of the process (both clinical and scientific) are controlled by us to ensure that all tissue grafts are quality assured.

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Call us on:

0845 607 6820

Fax:

0845 607 6819

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