With increasing regulatory pressure and greater demand for faster time-to-market, working with suppliers you can trust is critical. There is no margin for error in drug safety and process security. These factors underscore the work we do at King Filtration with respect to verifiable traceability for product contact filtration. It’s vital to manage the documentation, know where your filters came from and their exact materials of construction (MOC).
Our documentation system has been customized to meet Quality Process needs of our Pharmaceutical, Food and Beverage (FDA) and Chemical customers’ needs. Among the Quality Control procedures we follow are:
- Establishment of an Approved Filter List (AFL) to ensure you are getting the exact brand and part number specified for your process.
- Record and manage all documentation of incoming filters (Certificates of Conformance) along with lot and/or serial numbers and retain that documentation for a period of time as specified by the customer.
- Inspect all filters received are listed on the AFL by comparing the incoming shipments certificate of conformance and product labeling with the AFL to ensure that the filter is from the approved filter manufacturer and is the correct manufacturer’s part number.
- Inspect the received shipment of filters to ensure they are clean, intact, and free of visible damage.
- Ensure received filters are within the lot’s expiry/use-by date and are labeled with Mfr. Name, correct part number, lot number and expiry/use-by date.
- Manage all manufacturers change notifications, and alert to how those changes might affect your process.
This accountability ensures that filters, as delivered, are made with the exact materials specified and helps avoid costly risks due to unauthorized material substitutions that might affect the finished filter and the validated state of the equipment or process.
We can further enhance and customize a program to your exact requirements. If interested in learning more contact us at
email@example.com or call 800-999-8441.