INTRODUCTION

Parametric release is a practice to release finished product that relies on process control in lieu of end product testing to establish that a product is safe, pure, efficacious, and of suitable strength for commercial or clinical use. Parametric release is based on demonstrating that in-process conditions relevant to the establishment of key product quality attributes were attained and maintained throughout the relevant manufacturing steps. One attribute for which in-process controls would replace end product testing is sterility. The radiation sterilization of articles described in Radiation Sterilization 〈1229.10〉 performed in accordance with International Organization for Standardization (ISO) 11137 was the first sterilization process to use in-process controls and monitoring to replace sterility testing. The application of parametric release specifically to the attribute of sterility for commercial use requires prior regulatory approval.