I had a question recently, and am looking for some guidance on a Dietary Supplement. If anyone has any insight, that would be great, and it would be even better if one can cite a CFR or Guidance Document reference also.
Our co-manufacturer made a batch of powder to be encapsulated in a 2-piece hard shell. The batch is exhibiting poor flow-ability, and cannot be successfully run on the equipment. The proposed solution is to use this powder batch and add it to future productions at a 90:10 ratio. The claim is that this will have no impact on shelf life, and the new finished product will carry the same shelf life as if it were 100% newly blended product.
1. I have always understood that comingling a lot into compliance is not acceptable. I am unsure if this is only for critical attributes (organoleptics, label claim, etc.) and it is acceptable for certain physical characteristics, or if it is generally unacceptable all-around.
2. Regarding the shelf life: If it is determined that the proposed plan is acceptable, wouldn't it still have to bear a shortened shelf life unless we can show stability date that supports the entire lot having the shelf life of the newer production?
If anyone can help by providing any supporting documentation of why the proposed plan is either acceptable or unacceptable, it would be very helpful as we assess a path forward.
Thanks in advance!