Aseptic Processing and Terminal Sterilization

Abstract

With the increase in emphasis by the FDA on sterility assurance, representatives of the FDA have made statements regarding upcoming guidelines for parenteral processing mandating usage of terminal sterilization, where possible. The anticipated FDA guidelines may involve both pending NDAs and existing, approved NDAs. It is the position of the Parenteral Drug Association that ethical parenteral manufacturing firms provide a high level of sterility assurance without compromising the physical and pharmacological properties or stability of the product. This document presents the PDA’s position on the anticipated FDA guideline in addition to delineating some of the concerns and considerations surrounding aseptic processing and terminal sterilization.