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Quality assurance and regulatory compliance

Maintaining high standards of regulation to ensure quality and safety.

The Scottish National Blood Transfusion Service (SNBTS) works continuously to maintain and improve regulatory compliance. SNBTS needs to maintain the highest standards of regulatory and accreditation compliance to ensure the quality and safety of its products, to remain compliant with the law and to uphold the confidence of its stakeholders.

SNBTS is licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA). The MHRA regulates all blood activities and the production and supply of Cellular Therapy medicinal products. While the HTA licences SNBTS tissue and cells activities, professional inspections are also carried out by Clinical Pathology Accreditation (CPA) and the processing of blood stem cells is accredited by the Joint Accreditation Committee - the International Society for Cellular Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT).

The Quality department provides regulatory support and advice on Quality Management Systems (QMS) to all areas of SNBTS to ensure these high quality and regulatory standards are met.