Hi all, if we have a contract with other industry to produce vials for our industry and we only put labels and package should we mention in the label the name of the produced company? if the answer is Yes is there any reference or Guidelines?
No, it’s not required. In fact, it is a common practice to have an outside manufacturer of your packaging container. However, it is incumbent on you to perform a QA audit of this manufacturing facility and to ascertain the related substances from this container closure system per ICH Q3. In short, you must find the vials appropriate for your drug product.
For formulations in vial under contract manufacturing we have to put manufactured by and marketed by address.
No. You are the owner. My comments are still the same above. As long as you have an audit trail as required by cGMP, but it also depends on the regulations (non-GMP) of where you sell your product.