What is a GMP Permit: An Expert Q&A

Can you give me an example where production went wrong before you started to use GMP permits?

Duncan: We had completed a changeover and began the new process, and all was going well with the batches moving through the plant without any issues. Unfortunately, when discharging the first batch, there was an issue which seemed to indicate we had some form of blockage, the initial feed was fine but soon stopped coming through. Investigations needed to begin!

This meant downtime for the product as we prepared and organized the team. We had an idea of where the potential issue could be and first targeted the screw feeder. We straight away found the issue: IPA wipes. These were used during the cleaning of the equipment.

In this case, the cleaning had been completed, the swab test passed, and the equipment was re-built. However, a number of wipes had somehow been left either when the screw feeder was re-built or they had found their way into the screw feeder from the filter or the dryer. This meant we needed to clean down all the equipment to prove beyond doubt that all was clear of any other contamination.

Before we could do this, we still needed to discharge the remaining product, to test for the presence of fibers or, indeed, full wipes that could have found their way into the product. Sometimes you could re-work the batch. However, this would require more time to test to be 100% certain that was the case. The worse case scenario was the batch would be incinerated!

This issue was before we had GMP permits.

With a GMP permit, when you carry out a maintenance or cleaning task, you would count how many IPA wipes you were taking in for the task. And if you come out with less, then where are they? This would allow investigations to begin before the plant was re-built as ready for production.

What would have been the added benefit of using electronic permits/GMP permits? How could those have sped up your team’s operations even more?

Duncan: When we started a changeover each day we would have a morning meeting to discuss the tasks for the day ahead, we would then have the teams waiting to sign on to each task. You’ve got to imagine, these teams, they have a permit, and they are just waiting to be signed on. There are teams of three, four, five or more guys, and all are waiting to start the task because they cannot continue without the permit. This is valuable time.

So that’s where an electronic permit-to-work system would work really well. Firstly, all of the permits would be ready to go. Secondly, no more hand-written permits. Imagine the time saved not having to re-write a permit but being able to copy. It still needs to go through formal workflow, but it is much quicker. Remember, too, that there can be hundreds of permits associated with a changeover. The feedback from our clients is positive as to how digital permits have streamlined the whole way of working.

To carry out any task safely is a given but to also ensure that there can be no impact on the quality of the product coming through is equally as important, as this can ultimately have an impact on a patient.