Good post Mozzarc. I haven’t read that document for a few years...

Good post Mozzarc. I haven’t read that document for a few years but used to know it intimately. This is only one part as you have posted about the API. You then have to manufacture the vials and package, all of which needs validating and documenting in the same way. I did this for 20+ years of my working life and was involved in many FDA audits and preparing manufacturing centres for them across the world for both API and drug production. Given that iPPS has been manufactured and sold in the US for some time I do not have the data to know if an audit needs to be undertaken by FDA prior to approval for sale. I will investigate as some data is freely available on the CDC website.
Keep up the great research and posts.
Cheers