cGMP

Good Manufacturing Practice for cellular therapy, known as cGMP, are standards that are usually established by the federal government. Hence they may be different in each country, which is why international standards have sprung up, such as JACIE in Europe.

In the US, the FDA establishes GMP standards. The FDA applies GMP standards to drugs and medical devices. The new FDA BLA licensing requires that public cord blood banks to handle cord blood as if it were a drug, and follow the GMP standards.