Regulatory compliance

You're in safe hands

All services provided by NHS Blood and Transplant (NHSBT) are delivered in accordance with quality management principles. This means that all work is carried out in accordance with good laboratory practice (GLP) or good manufacturing practice (GMP). Techniques and procedures are validated, described in standard operating procedures, and conducted by staff whose proficiency is monitored regularly.

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

  • Good Manufacturing Practice
  • 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
  • NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
  • British Pharmacopoeia
  • The supply of unlicensed medicinal products (“specials”) MHRA Guidance Note 14

All laboratories participate in External Quality Assurance Schemes (e.g. NEQAS) where applicable and, where appropriate, in international workshops. The laboratories are working continuously to improve quality and effectiveness and best practice is formulated through a philosophy of continuous improvement.

Our quality assurance team members are always pleased to share their expertise with colleagues in the wider NHS and academic groups. This might include informal auditing of local quality systems, advice on compliance with regulations or guidance on the design of GMP facilities.

Please contact us to discuss QA support further.

Advanced therapy medicinal products

Advanced therapy medicinal products (ATMPs) are a complex and wide-ranging group of gene and cell therapies and tissue engineered products. We understand the complex and evolving regulatory environment for ATMPs and have a long history of regulatory compliance in this field.

Whilst ATMPs are governed by standard regulatory requirements for medicines, there are also several specific guidelines relevant only to ATMPs. Each of our GMP laboratories operate in a highly regulated environment, authorised by the Human Tissue Authority and the Medicines and Healthcare products Regulatory Agency.

We aim to offer affordable regulatory advice and quality assurance support to internal, NHS, academic and commercial customers with our core focus being European (EU/EEA) Regulatory requirements for ATMPs.

Please contact us to discuss QA support for ATMPs.

Licensing

We have multiple licences and accreditations including:

  • MHRA MIA IMP (25224)
  • MHRA MS ‘Specials’
  • GMP Quality Control (Veterinary)
  • HTA
  • JACIE

Please contact us for further information about our licenses.

Contact us

Email: CMT@nhsbt.nhs.uk