Quality and Regulatory

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 - ISCT & EBMT (JACIE).

The Quality Directorate provides regulatory and Quality Management Systems (QMS) support and advice to all areas within SNBTS to ensure we meet the expected quality and regulatory standards. Increasingly, it also provides advice on QMS to peripheral blood banks and hospitals within NHSScotland.

Specific activities within the Directorate include the following:

• Development of a functional QMS which meets the needs of appropriate regulatory bodies i.e. MHRA, HTA, CPA and ensure ongoing approval by these bodies
• Provides a lead on quality related matters within SNBTS, and administers the key elements of the Quality management system, including documentation, validation, change control
• Carries out audits of compliance with SNBTS policies and procedures and takes an overall leading role in the follow up of quality related incidents
• Provides the focus within SNBTS for effective communication, investigation and management of quality related problems, to raise standards and promote the concepts of continuous improvement and customer satisfaction