A Code of Practice for the Production of Human-derived Therapeutic Products

This Code of Practice provides guidance for organisations that produce healthcare products containing material of human origin.

The information is relevant to organisations that supply to the UK Health Service, such as specialised hospital units, manufacturers and others.

It outlines principles and systems that are fundamental to safety and quality, in a easily useable form. The code reflects current scientific state of the art and professional standards accepted by commercial organisations, institutes and Health Service establishments.

Examples of products anticipated to be within the scope of this document include:

• Human skin cells in a matrix, used to treat diabetic ulcers or burns victims;
• Cartilage cells grown in a lab, for treatment of joint injuries;
• Cells to treat injury to the surface of the eye and help to prevent blindness.

Some of these are currently under development.

The document builds upon the 'Code of Practice for Tissue Banks',and 'Guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in Transplantation'. Both these Department of Health documents were published in 2001 and 2000 respectively.

This latest Code of Practice was produced by the Medical Devices Agency in consultation with the Medicines Control Agency, interested professional organisations, commercial producers and specialised hospital units. The document was published in June 2002.

The full document can be downloaded as a PDF file, free of charge. A printed version is available for sale at £25.

Requests for printed copies should be made via E-mail - dts@mhra.gsi.gov.uk, fax (+44 (0)20 7084 3124), or letter to: Business Services, Medicines and Healthcare products Regulatory Agency, 2 Floor, 1 Nine Elms Lane, London SW8 5NQ.

Technical enquiries about this Code of Practice should be made to Jeremy Tinkler at the above address, or E-mail: Jeremy.Tinkler@mhra.gsi.gov.uk.

Note concerning viable animal cells (or tissues): Where these are incorporated in products and/or used during processing, the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) should be contacted (http://www.advisorybodies.doh.gov.uk/ukxira/index.htm)