RT Journal Article
SR Electronic
T1 Aseptic Processing and Terminal Sterilization
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 254
OP 258
VO 45
IS 6
YR 1991
UL http://journal.pda.org/content/45/6/254.abstract
AB 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.