FDA PAI Prep: The Aseptic Olympics Are Coming
You know that feeling when you’ve just completed a massive project, validation is complete, and you’re ready to ship product? That sweet relief is immediately followed by the cold dread of realizing the FDA Pre-Approval Inspection (PAI) is looming…
In aseptic manufacturing, the PAI isn’t just an inspection -it’s the regulatory World Series, the Aseptic Olympics- success demands a flawless routine without dropping any SOPs. The medal is market access; the judge is the FDA.
