The new ePedigree, UDI and chain of custody regulations that will start going into effect in 2015 require a complete history of all pharmaceutical and medical items to ensure that the product’s device history is readily available. While most life science companies have excellent systems in place or in process to cover activities within their own manufacturing environments, the new regulations may require item genealogy information from suppliers that ensures the component items meet specifications. This is true even for nonwoven textiles.
Nonwoven textiles are important components of a variety of medical items, found in products ranging from simple adhesive strips to disposable filters, sterile surgical drapes and implantable mesh. The company manufacturing the textiles may not even know its ultimate use, which means your in-house product engineers must carefully define specifications and requirements for product documentation such as certificates of compliance.
One way to ensure that your product supplier complies with the new life science documentation requirements is to select a partner who is familiar with your industry and the ways in which medical devices use nonwovens. If a company does a substantial portion of its business with customers in the medical device industry, you can be certain that they understand and are able to comply with the cGMP and UDI regulations. You can consider it an added bonus if they are ISO regulation certified as well. Since almost any ISO certification requires process documentation and adherence to procedures, it’s a good bet that the company can easily adapt to the emerging requirements to meet the new industry compliance rules.
In addition, careful specifications describing your needs, including product labeling, tolerances and sourcing of component materials, will help to ensure that the nonwoven textiles included in your product meet the new regulations. If you find a manufacturer who can work with you as a partner, rather than a simple manufacturing vendor, you can be assured of excellent quality product and superior service.
Do you request quotations from your manufacturing partners? This checklist provides handy tips on creating an effective RFQ that will ensure the estimates you receive are on target with your project goals.