Increased Process Understanding Drives FDA Approval of Parametric Release
For terminally sterilized product, parametric
release can be granted by regulators
when firms have demonstrated thorough
control of their sterilization processes using
defined critical process controls. This
enables the release of product for commercial
sale without performing sterility
testing on each product lot.
Sanofi’s Ridgefield, N.J. facility was the site of a parametric release implementation