A few material suppliers are faltering in today’s unstable economy, so you could be using a packaging material that may not be available later this year. Suppliers may be shutting down entirely, or they may be discontinuing certain less-profitable formulations.
If a long-used material or component should suddenly be pulled from the market, will you be prepared to make the switch to an alternative?
For nonsterile drugs, interchangeability itself may not be the issue. Claiming equivalency may not be as tough as you think. FDA allows many changes to be made with only a 30-day notice and some through annual reports. For instance, in “Changes to an Approved NDA or ANDA,” a change in the container closure system for nonsterile drugs only requires a notation in an annual report provided that the alternative can be shown to be equivalent to “the approved system under a protocol approved in the application or published in an official compendium.” Annual updates are also acceptable if the new package provides the same or better protection against moisture and light and has been used for CDER-approved solid oral dosage forms. (If a new material is being used for contact with a drug but has not been used for a CDER-approved product, you’ll need to submit a Changes-Being-Effected-in-30-Days supplement.)
Finding out which materials are already being used for CDER-approved packaging may be a bit of a challenge. FDA says that an Inactive Ingredient Guide is available from the agency. If you can’t find locate a particular material on the list—or the list itself—you can use “reliable” sources of information, says the agency. Trouble is, suppliers are often under confidentiality agreements, and competitors may not want you to know. If you can’t find proof, you may need to submit the change for a single NDA or ANDA.
Say you do find “reliable” data that show the alternative material has been used on a CDER-approved product. Your next question should be, are its Drug Master Files available and current?
Next, if the material contributes to the child resistance of a packaging, such as paper-backed foil, and you have to replace it, will you need to redo child-resistance and senior-friendliness tests?
What about other usability and performance tests?
If a functional package component is changed, such as a heat-seal coating, will you need to develop (and validate) new process parameters, such as new sealing parameters? Will you need new or updated machinery?
The good news, says Peter Schmitt, managing director of Montesino Associates, is that equivalency can be established—and FDA will most likely accept your claims, with proof. The tough news is that you will need to consider all the ramifications of a switch.
Perhaps the safest course of action is to put in place a back-up plan before you need one. Frank Bieganousky, also of Montesino, advises a strategy of redundancy in the supply chain for critical packaging materials and components, robust technology options, and supplier options. It could save you from a last-minute mad dash to prove equivalency in performance, production, and use.