In a medical device manufacturing environment, where research and development work is also performed, is it okay to have some expired materials on-hand for experimental use? For some exploratory work it may be desirable to use an expired material to save having to remake it fresh or to save on expense. These expired raw materials and in-process materials are few in number, are clearly labeled “For experimental use only - not for production use,” are segregated from manufacturing materials, and will not be used for important studies or validations - they are only used for side experiments which are repeated with in-date materials if needed for a development report or such. If you could reference a FDA or ISO document, that would also be helpful.
BTW, we have been discussing this for years at our company, but nobody seems to really know how the FDA handles this.
I’ve done something similar at an FDA regulated pharmaceutical manufacturing company (not medical device, but with similar principles). We had an R&D arm, and a commercial manufacturing arm. The biggest are where mix-up could occure was with lab equipment, and sometimes scale-up manufacturing equipment. The key was to put in place good practices so that there are no mix-ups between GMP material/equipment and non-GMP material/equipment. Again documenting how you avoid mix-ups is critical.
For example you may avoid mix-ups by documenting your practices doing any/all of the following:
Correct labeling of non-GMP items (big red label "For development only"
Correct training on use on R&D items
Physical separation of R&D items. You could have a separate lab, or a separate facility, or a separate cabinet, which is also labeled R&D only.
Log books or commercial production records which require the user to document material lot #, and material expiration date (this is probably the easiest and more sure way of ensure there are no mix-ups).
Whatever practices you choose, make sure you put the segregation policy in an operating procedure. Basically, if you show control over your process, and that your process is documented, and that you effectively follow the practices, then no auditor can criticize you for using expired items for R&D.
I do have one question. R&D eventually leads into clinical study, or a regulatory filing, I assume. I’m not in regulatory department - but you may not be able to use data from R&D to support filings, if the data was generated using potentially compromised material (expired material). I would ask your regulatory group what data can be used in filings. For a comparison, I do know that equipment used for R&D for regulatory filing must be calibrated and qualified so that there is a degree of assurance that the results of the R&D studies are reliable; this is probably similar with materials, it should be valid in order to be used for regulatory filing data submissions.
I hope I’ve communicated that correctly.
Thanks for your reply. If one of our studies using expired material yielded results we would want to use to support our development work, or use in a validation, we would then repeat the experiment with in-date material. So in my mind there should be no problem. I’d just like my mind put at ease by someone who has already dealt with the FDA on this issue so I don’t have to guess at their opinion. Your reply sounds very logical: good labeling, separation and documenting how you handle this.
The reply above is very good and should be followed. I would also ask ‘Do you want to take the risk’? If the device your manufacturing passes, it will have to be confirmed (why do something twice?). If it fails, ‘then what’? Ask Takata about their airbag initiators!