PDA Letter Article

PDA Responds to Annex 1 Revision

by Rebecca Stauffer, PDA

PDA recently released comments on the Annex 1 revision from a commenting team.

While the team appreciates that the revision clarifies certain areas, such as aseptic process simulation acceptance criteria of zero contaminated units, the team is concerned about new requirements for post sterilization, pre-use filter integrity testing (PUPSIT) and placement of settling plates in grade A critical areas.

Read more about the team's comments.