Non-product-contact packaging components - CofC or GMP required?
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
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.
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.