Long winded ask so apologies in advance:
1. Has anyone gone through a GRMA audit AND they manufacture with spore formers and probiotics?
2. We are a dietary supplement contract manufacturer and recently the discussion surrounding spore forming probiotics has come up. We have discovered that we have been manufacturing with micro-encapsulated spore forming probiotic for years and we have not done a cleaning validation surrounding spore formers specifically nor do we have dedicated lines and equipment for spore formers, although we do know that we do not run it through any blending equipment to prevent the destruction of that micro encapsulation. We also have an extensive dust collection system but it is shared so we do not have dedicated dust collection for the spore formers either. What is our risk other certifiers and the FDA?
* Please note we have apparently been manufacturing with spore formers for years but it has not come up in any audit
