The Medicine and Healthcare products and Regulatory Agency- UKSCB requires an external contractor (third party) to provide viral testing for the EU Tissue and Cellular Directive (EUTCD) compliant human embryonic stem cell (hESC) lines. UKSCB is licenced under the HTA Human Tissue (Quality and Safety for Human Application) Regulations 2007 for the production of starting materials for clinical application. According to HTA regulations any testing activities that are subcontracted to external contractors must be appropriately validated to demonstrate that the testing method is suitable for the product analyte. In addition, the contract laboratory has to be accredited by the regulatory body for the licensable activities. It is estimated that the contract will run for at least three years and will cover testing of approximately 38 hESC lines. Only contractors that are accredited to carry out viral testing on human cell lines will be considered.
Blanche Lane, South Mimms
Published: 21 Jun 2018, Receipt by: 20 Jul 2018
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