Regulating Space-Made Medicines: the FDA and Manufacturing Rules
How would a medicine with a manufacturing step in orbit be regulated, and what stands in the way?
Chapter summary
no regulator has yet approved a medicine with a manufacturing step performed in orbit, and the FDA has issued no specific guidance.
Key takeaways
- 1
Medicines must be made under good manufacturing practice (GMP): validated processes, controlled facilities, trained personnel, quality testing and inspection.
- 2
Those rules assume a factory on the ground that inspectors can visit.
- 3
In orbit, there is no on-site inspection, no operator and limited in-line testing.
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