Medical Device Link.

Can someone give me some insight with regards to what the FDA requires for "sterilized packaged product"? Is the burden of maintaining validation for both the packaging and sterilization on us IF we utilize an outsourced service? Our scenario is such that we manufacture the product itself. My company is inclined to send our finished product out for packaging and sterilization. We may also consider packaging the product in house THEN sending the packaged product out for sterilization. We are currently considering EtO and Sterad methods of sterilization. Any insight is greatly appreciated. - Jeff

Jeff,
The FDA uses ISO 11607 for packaging requirements. The standard includes responsibilities of both supplier and manufacturer. As long as you comply with this standard and fully document everything you'll be grand.

Good luck!

The burden of maintaining validation for both the packaging and sterilization rests with the manufacturer of the product. Thus if the product is registered by you and commercialized under your name, you are responsible.

If you use contract packagers & sterilization they can assist you to validate their processes but you are responsible for the quality of the validation.

Since you are responsible, you should be actively involved in your supplier's QS audits, which should include a review of their packaging / sealing, and sterilization validation packages. Periodically you should do a sanity check by random sampling and sending packaged / sealed / sterilized product to a lab for a sterility test. Maintain documentation on the above in your vendors' file(s).