ASTM establishes new subcommittee on E-55 PAT Committee

The new subcommittee, headed by former Sanofi-Aventis PAT expert David Radspinner, now with Thermo Electron, will deal with issues such as calibration and validation as they impact control.  Read more about it here. Observers in the industry question how PAT standard setting will proceed, and whether USP will play any substantive role in the future.  USP has been developing its own standards for PAT, but its efforts appear to be diverging from those of E-55 in some areas, and E-55 has already become the predominant global PAT standard-setting group. However, since USP recommendations still guide many pharmaceutical manufacturing operations around the world, some consensus between the two standards-setting groups could help bring clarity to drug manufacturers that are embarking on pharmaceutical PAT implementation projects. -AMS