Thoughts on FAT

The cGMP report is silent on the subject of FAT. There are no protocols to be followed to ensure that everything is working, and no checklists for pre-shipment. To fill that void, some manufacturers are developing their own procedures.

Testing work can add significant cost and time, but it's critical to the success of the project. "By putting these processes in place, we can do work at the point that it makes the most difference," says Schuh. "Some customers are looking into executing portions of the commissioning work during the FAT in the supplier's factory, with the goal of trying to improve the overall efficiency of a given project. It's getting mixed results, but it's a great example of people working together to optimize program results."

This collaboration might well be the key to success in easing the overall validation burden. Packaging suppliers need to better understand quality systems, which in itself is a huge challenge for smaller companies. Pharmaceutical companies can help by working with suppliers to help them understand what they need to get out of the process.

--By Brian Pelletier, Contributing Editor