What is a GMP Permit?: An Expert Q&A

Pharmaceutical Manufacturing
February 04, 2021

Shutting down parts of a drug production plant for routine cleaning and maintenance work is inevitable and expected. But sometimes downtime is not planned for and the longer the plant is shut down, the more production gets delayed and, ultimately, the longer patients have to wait for their medication.

I spoke with Duncan Cole, project manager at Wolters Kluwer Enablon, about his experience with using GMP (Good Manufacturing Practices) permits and how the introduction of these helped to ensure unplanned downtime was kept to a minimum, helping keep production running on time, in his industry days at Novartis, where he spent a 20-year career in product manufacturing and operations.

GMP permits. What are they, and why are they important for ensuring product security and safety?

Duncan: So basically, you’ve got your main permit to work and this basically tells you what task you have to do and has associated risk, isolations certificates, etc. and follows our usual process.

However, when working within a pharmaceutical facility, there is also the need to consider the use of a GMP permit. This is to prove that you’ve done everything that you could possibly do to ensure the area around the place of work is free from contamination before you begin a task.

This is especially the case when preparing for a break-in to the production plant, post final filtration. The GMP permit has a workflow that needs to be checked through with each stage signed off once completed. Such items would be: ensuring the area is clean, there are no visible areas whereby contamination could enter, reconciliation of tools or cleaning materials, and so on.

Duncan Cole

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.

 

This is the second Q&A post in a four-part series with Duncan Cole, Project Manager at Wolters Kluwer Enablon. Read the first one here. And keep following our blog for the other two posts.

On-Demand Webinar: How Pfizer Defines EHS & ORM Synergies

Gavin Farrissey, Warehouse Shift Leader at Pfizer, explains the journey of implementing an electronic permit-to-work solution and shares lessons learned. Learn how Pfizer has gained efficiency with an ePtW system, and how the partnership between Pfizer and Enablon resulted in a template for best practice to integrate EHS and ORM.

Author

Tina Amirtha

Tina Amirtha

Product Manager at Wolters Kluwer | Enablon