Blending Lots

Hello,

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!

Scottaha,

If the powder meets the "purity, strength and composition" requirement in 21 CFR 111, and it is just a process-ability issue, I would think that blending it would not cause you to be out of compliance.  Does looking at 21 CFR 111.70 regarding specifications help? We had an issue once where the lot of material testing at the upper limits of acceptability and we put it in at a different usage rate than the process called for.  It was all documented in the records and the final testing showed the finished product in compliance.

I think that if you write a detailed disposition and corrective action plan, and keep it with the batch record, you should be OK.  I cannot really speak to the shelf life issue other than to recommend you err on the side of caution and either test it (if you are able) or defer to the shortest shelf life (based on oldest ingredient inventory)  based on your components.

FDA has been in numerous times and looked through my records.  I think as long as you can justify your corrective actions, and the final product meets the specification in your master manufacturing record, you should be OK.

Good Luck!

Hi Ksullivan,

Thank you for the input!  I think we are in agreement that the reason for the blending is not unreasonable, as we are not "blending/comingling into compliance," but I do still struggle with the shelf life.  I think some sort of accelerated stability is necessary to justify the extended shelf life of the material.  

Thanks again!

Ah...an old professor always told me, "The solution to pollution is dilution."

Basic rule of thumb, you cannot dilute out "adulteration."  Aside from that...happy diluting.

Hi,

for me it sounds like a kind of rework, i.e. the composition is ok, but the flow-ability is poor (machinability). If this would be only an effect influencing the manufscturing process and not the application of the product, such rework of materials is possible.

At the end:  You have to meet all parameters of the final product spec and all legal requirements.

Rgds

moskito