Last month we wrote to all the foodies on how to survive a warehouse audit. We called it our ”Food Warehouse Audit Survival Guide.” This month, we’d like to take on another industry that owns and operates warehouses: pharmaceuticals. In keeping with our oh so original title, we present the ”Pharmaceutical Warehouse Audit Survival Guide.”
Rule #1: Be smart about automation.
"There aren't any manual processes anymore," we've heard from our customers. ”Everything is done by machines.” Our advice to those of you who are thinking of automating a new processes within your warehouse, be smart about it. Be sure to test, validate, and document all automated processes. Oh, and backup plans and systems may not be a bad idea either.
Rule #2: Know the different kinds of inspections.
There are three types of FDA inspections:
- Pre-approval inspection of a facility after a company submits an application to the FDA to market a new product
- Routine inspection of a regulated facility
- "For-cause" inspection to investigate a specific problem that has come to FDA’s attention
You will most likely deal with routine inspections of a regulated facility, and hopefully will never have to deal with a ”for cause” inspection. Understand the details of each inspection type, and then prepare for that inspection.
Rule #3: Abide by a more stringent warehouse temperature range.
Most pharmaceutical warehouses will find themselves being forced to keep the temperature of their facility between 55-85F. That is a very broad temperature range. Find a happy middle, and stick to it. Don’t set your monitoring alarms for 55F and 85F. That’s when it is too late!
Rule #4: Send everyone chocolates.
We are kidding. While you should never bribe your auditors, you should know their names, their function, and how they are going to interact in your facility. For some of you larger warehouses, you may have an FDA inspector who is on site for much of the year, along with a QA manager and a team of internal auditors who are continuously monitoring all of your products and processes. Create an open communication pipeline with these people. Not through chocolates, but with a shared interest in making the storage of your pharmaceuticals as safe as possible.