Quality assurance

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
  

• Guidelines for the Blood Transfusion Services in the United Kingdom

• Department of Health: A Code of Practice for the Production of Human-derived Therapeutic Products

• FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration 8th Edition (2021)

• The Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

All laboratories participate in NEQAS (National External Quality Assessment Service) 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. 

Additionally by arrangement, prospective and existing service users are always welcome to inspect or audit the stem cell laboratories, clinics and offices,please email cmt@nhsbt.nhs.uk.

Complaints

Please address to the relevant Laboratory Head in the first instance. Complaints are logged, investigated and resolved. We strive always to provide a satisfactory response to your complaint; however 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