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Wednesday, October 27, 2021 6:31:07 AM
The Human Tissue Authority (HTA) ensures that procurement, testing, processing, distribution and export of tissue and cells for human application is performed in accordance with the quality and safety standards of EU Directive 2004/23/EC
Patients adipose tissue are harvested under Human Tissue Authority (HTA) licenced procurement procedure, in a CQC registered hospital and manufactured under a The Medicines and Healthcare products Regulatory Agency (MHRA) licenced GMP cleanroom facility , Royal Free NHS
Lab Processing / Manufacturing – MHRA Licence
MHRA Licence –
The manufacturing step to obtain adipose derived stem cells and returning them to a patient for medicinal purposes falls under the Medicines and Healthcare Products Regulatory Agency (MHRA). To make human medicines, providers require a manufacturer licence, issued by the MHRA. To qualify for a manufacturer licence providers need to demonstrate to the MHRA compliance with EU good manufacturing practice ( GMP ) and pass regular GMP inspections.
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