2 replies to this topic

[matthewcc]

Hello, I am not sure if this is on the right forum, but for a non-product-contact packaging component, e.g., a bottle neck seal, would a supplier need to have a GMP program in place, and would they need to provide certificates of compliance for their products?  This is for a dietary supplement in the United States.

 

Thank you,

Matthew

[FirstQualityConsulting]

Without knowing the exact nature of the bottle-neck seal and how it impacts the product, I would error on the side of caution and say "Yes" all suppliers of primary and secondary packaging should have a GMP program and/or a COC.  Otherwise you will not know if the seal poses a contamination risk.  If these suppliers do not have a GMP program or cannot provide a suitable COC, then at minimum a risk assessment and justification as to why there is no risk must be performed.  But even then, I would find another supplier.

[steliosa]

hello, i agree a GMP is needed. But concerning CoC, you must ask for compliance for a specific regulation. In this case, which could be this regulation? i Doupt it exists. So it becomes a grey area.