How did you address the GMPs? Such as hair nets and lockers?
We have a large facility and only a few machines will be running food packaging products - though food packaging is only 10% of our product mix and so we do not run it often. My thoughts are to complete a full risk assessment of the entire facility not having to use hair protection but when we do run the products that the operators of those machines follow a rigourous cleaning and hair nets policy.
We also have lockers placed all around the production floor, not in a central location but we do have a lunch room which employees store their food their prior to entering production. Is this a problem?
We addressed by making the area where food operations happened our GMP controlled area. This was a small operation doing dry steam sterilization/pasteurization, so the part of the warehouse with our food storage and heat chambers was partitioned off and GMPs were enforced in this area. Only cross hazard was where we drove from the GMP area to the loading dock, and our policies dictated that no other loading/unloading was to occur at this shared dock space while we were moving food, and the food had dedicated dock doors. Believe me, there was always a lot of "we're doing our best with limited space and business needs" type statements to the auditors, and it took them time to accept it but they never found fault when they poked and prodded our programs.
When I say small operation, I mean one production employee, one plant manager, and me a shared QA role between this building and the one next door (family run operation). Our breakroom and employee storage was in an office directly leading to the GMP area, handwash sink and smocks kept immediately outside that office leading into the processing area.
From what you're describing, I'd want the entire area around these food machines regulated as a GMP area. If packages can be sealed inside this area after production, I'd argue all day long that it's fine to then transport the goods through the rest of your non-GMP production on the way to storage. But you'll need to establish and risk assess your traffic flows, to make sure the employees traveling to the GMP area aren't picking up environmental hazards on the way (or mitigate those hazards once they enter the GMP area: handwash, smocks, shoe coverings, etc).
As for the lockers, I'd recommend removing them. Auditors are going to argue that any employee storage in the production area is a risk, because you can't say for sure your non-GMP employees aren't storing things like food in their non-GMP area lockers. Auditors are free to examine the non-GMP areas to determine if they find a risk to the food operations you're trying to perform, even if the area is out-of-scope they're going to argue certain parts of the program must be enforced to protect the GMP area.
As I hinted earlier, it's not impossible but you're going to have your work cut out for you...
Edited by jfrey123, 25 January 2024 - 05:29 PM.