Points to Consider No. 1: Aseptic Processing (Revised 2023) offers PDA’s thoughts and does not represent a standard or regulatory guidance.
PDA first issued Points to Consider for Aseptic Processing in 2003. To address the impact of the knowledge gained in the intervening years, PDA assembled a task force of subject-matter experts from industry to revise this report. Published in 2015 and 2016, Points to Consider for
Aseptic Processing parts 1 and 2 provided positions on current topics, best practices, and areas of clarification important to the manufacture of quality sterile products.
