Regulatory compliance

You're in safe hands

All services provided by NHS Blood and Transplant (NHSBT) are delivered in accordance with GxP (including Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice and Good Distribution Practice).

Processes are fully validated, described in standard operating procedures, and performed by staff who are trained and competent.

The Clinical Biotechnology Centre (CBC) and Advanced Therapies Units (ATU) are supported by a dedicated Advanced Therapies and Medicinal Products quality assurance (QA) team, with expertise in the regulations of Advanced Therapies.

Our key regulators are:

• Human Tissue Authority
• Medicines and Healthcare Products Regulatory Agency (MHRA)

CBC and all our ATUs hold a Manufacturing Authorisation for Investigational Medicinal Products (IMPs) from the MHRA. All our Stem Cell and Immunotherapy (SCI) sites hold HTA licenses.

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

• Good Manufacturing Practice
• FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration
• Department of Health Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation
• Department of Health: A Code of Practice for the Production of Human-derived Therapeutic Products
• NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
• The supply of unlicensed medicinal products (“specials”) MHRA Guidance Note 14
• The Human Tissue (Quality and Safety for Human Application) Regulations
• Human Tissue Act