Unlike vague regulatory text, PDA TR1 provides action levels and alert levels for viable/non-viable particles. It clarifies where to place settle plates, when to use active air samplers, and the significance of glove fingertip sampling.
The 2023 update to is the most significant in a generation. It harmonizes with the dramatic rewrite of EU GMP Annex 1 (2022) . Key updates include: pda tr1
But here is the catch: If your current aseptic processing strategy is still based on the 2007 version, you are already behind. Unlike vague regulatory text, PDA TR1 provides action