Dear MSE Community Members, With the growing interest in AI and Digital Twin technologies across CMC and pharmaceutical manufacturing, I'm interested in learning how different organizations are implementing these models and preparing them for regulatory ...
Hello all, For tomorrow's meeting on comments for SUPAC guidance on Manufacturing Equipment Addendum. Going through the addendum I did not find any information on actual scale-up for the pharmaceutical equipment for various processes. It has information ...
All MSE community members are invited to provide comments on the FDA guidance document, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-manufacturing-equipment-addendum . We will be holding a community session on Thursday, ...
All MSE community and general AAPS members are invited to provide comments on the FDA guidance document, SUPAC: Manufacturing Equipment Addendum . We will be holding a community session on Thursday, May 21st at 1:00 pm EST to discuss your comments ...
The FDA is seeking feedback on the SUPAC guidelines that apply to manufacturing process changes upon scale-up. Presumably members of this community might like to provide such feedback. For details see the recent post in the AAPS CMC Community for more ...