Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

What quality assurance steps are taken?

April 26, 2017quality assurance steps

0

Posted

What quality assurance steps are taken?

1 Answer

0

Posted

AMNIOGRAFT® and PROKERA® are procured and processed according to Good Tissue Practices (GTP) regulations and Good Manufacturing Practices (GMP) regulations established by the United States Food and Drug Administration (FDA). Placental tissues are retrieved from donor mothers after elective cesarean section under full informed consent. The donor mothers are screened at delivery for infectious, malignant, neurological and auto-immune diseases and other exposures or social habits to determine the suitability for human transplantation.