06/18/2026
EU GMP Annex 1 doesn't just describe a cleanroom. It describes a contamination control philosophy.
Personnel are explicitly identified as a primary contamination risk. Automation and barrier systems are encouraged to minimize human touchpoints. Every step in the process is expected to be justified, documented, and repeatable.
Manual footwear protocols - shoe covers applied inconsistently, mats that go unchecked, sprays mixed inconsistently, don't hold up against that framework.
An automated shoe sanitation step at every personnel entry point does. Same cycle. Every time. Every person.
That's Annex 1 thinking applied to a part of the facility most teams haven't gotten to yet.
Learn more: patho3gen.com/industries/pharmaceutical/