PDA Letter Article

Implementation Proves Parametric Release Possible

by James Assini, Sanofi


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