If validation documentation is done earlier, the Factory Acceptance Test (FAT) can be a simple procedure, but not always.
"It used to take only a couple of hours to make sure things were running properly during a factory acceptance test, but today it can take eight to 10 weeks to put the equipment and software through the necessary challenges to demonstrate that it will meet today's quality compliance standards," says Bikash Chatterjee, COO of consultancy Pharmatech Associates.
"We need to make sure that the equipment will meet all the user and functional requirements, which means we spend more time at the factory where it's more efficient to fix things in the supplier's factory than on the customer's shop floor," he says.
"Some customers are doing FATs in factories and are there for weeks on end," says Dave Schuh, VP of sales and marketing at MGS Machine Corp. "But the challenge is to understand the full scope of the FAT requirements, and fit it within the scope of work up front so that everyone wins."
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
