Quality assurance

Total quality management

Stem Cell Services are committed to a philosophy of total quality management. This means that work is carried out according to good laboratory practice (GLP) and good manufacturing practice (GMP). Techniques and procedures are validated, described in standard operating procedures, and conducted by staff whose proficiency is monitored regularly.

Our quality assurance experts regularly audit laboratory procedures against a range of regulations and guidelines. These include:

• Department of Health Advisory Committee on the microbiological safety of blood and tissues for transplantation
• General Haematology Task Force of the British Committee for Standards in Haematology
• Medicines and Healthcare products Regulatory Agency – advanced therapy medicinal product (ATMP) regulations and licensing
• FACT-JACIE International Standards for cellular therapy product collection, processing, and administration
• The Orange Guide: rules and guidance for pharmaceutical manufacturers and distributors
  
  

National external quality assessment service

All laboratories participate in national external quality assessment service (NEQAS) schemes and where appropriate, in international workshops. The laboratories are working continuously to improve quality and effectiveness. Best practice is formulated with the support of a Stem Cell Strategy Group. If you have suggestions for improvements please email cmt@nhsbt.nhs.uk

Request to visit the stem cell laboratories

We welcome prospective and existing service users to inspect or audit the stem cell laboratories, clinics and offices, please email cmt@nhsbt.nhs.uk to arrange.

Complaints

Please contact the relevant laboratory head in the first instance.

Complaints are logged, investigated. and resolved. We strive to provide a satisfactory response to your complaint. If you are unhappy with the outcome of a complaint you may contact the head of Cellular and Molecular Therapies (CMT) by emailing cmt@nhsbt.nhs.uk