Good manufacturing practices (GMP) have made warehouse mapping an essential component for any business that deals with warehouse storage. This is especially significant for those that operate within industries such as life sciences and food & beverage where stringent regulations necessitate the close monitoring of climate-controlled environments.
In our last blog post, we walked through how warehouse mapping works, including what to expect during the IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) stages.
In this month’s blog, we’ll tackle some of the additional questions you might have about warehouse mapping, not the least of which includes how to pick a trusted validation service provider.
Is warehouse mapping a one-and-done approach?
From constructing a validation plan to the actual logging of data, warehouse mapping can take weeks to complete – sometimes longer depending on the recommendations and how companies choose to address them.
Once complete, the question we at Alpha Controls typically get is whether warehouse mapping is a one-and-done approach?
In many cases, we will recommend continuous monitoring, particularly for zones that might have fallen into an excursion during the mapping process or areas where temperatures were running borderline.
Continuous monitoring generally won’t require hundreds of loggers though. For a 45,000-square-foot-area, for example, Alpha Controls might recommend 10 to 12 loggers into key positions where there were deviations, or where they came close to setting off an alarm.
Can companies map on their own?
The next question we typically get is whether warehouse mapping is something they can do themselves. Some do, particularly those that are large enough and are required by regulatory bodies to map their warehouses frequently – say every three to six months.
However, what many find out is that by the time they purchase all the equipment that is required and take the necessary steps to meet the guidelines, which includes using secure software that also has to be validated, it ends up costing more than what it would if they just had a third party do it.
In addition, some regulations require an objective third party to handle the mapping to avoid the potential for bias. This is especially the case in industries such as pharmaceuticals and the storing of vaccines where the margin for error is very small.
Is all warehouse mapping considered equal?
Lastly, and perhaps most important, is how to choose a third-party to perform the validation. The accuracy of the mapping varies based on the equipment being used and the technicians operating it. Data loggers have to be certified to meet the temperature specification, which is plus or minus half a degree Celsius. At Alpha Controls, we use validation equipment from Fluke Calibration, and Kaye Instruments, two of the world’s most respected brands in this field.
Generally, though, everybody has data loggers. The difference is how a company uses them and how that company documents the mapping for the customer. When selecting a vendor, it’s important for companies to ask to see examples of their documentation. Do they have experience with warehouse mapping? Can they provide references and testimonials?
Can you validate a warehouse with the right protocols that are recognized by different regulatory bodies? For most companies in Canada, that will most likely be Health Canada. But depending on where the business takes them, it could also include USP, or U.S. Pharmacopeia, and ICH, or the International Council for Harmonisation.
At Alpha Controls & Instrumentation, we will walk customers through a typical mapping process from start to finish – including sample protocols and procedures, all the way through to the final report. Our intent is to be as transparent as possible before, during and after the mapping process so customers have confidence when they decide to work with us.