Warehouse mapping is essential for any business that operates with its own storage and logistics requirements. Indeed, storage mapping is one of the keys to commercial success that distinguishes some organizations from their competitors. Why is it so crucial in the current climate?
Like many other sectors in the economy, the life sciences industry relies on warehouses and storage solutions as a part of its supply chain and so products can be safely and expediently released to market.
In both regards, warehouse mapping helps pharmaceutical manufacturers and biotech companies operate in full compliance with greater efficiency while delivering improvements to their quality control.
There are so many factors in modern storage mapping to consider when you start to think about it. From temperature controls to the regulatory framework, all can play a part.
Read on to find out more about today's warehouse mapping challenges and the right solutions that will help your organization to overcome them.
Understanding Validation and Qualification With Respect to Storage Mapping
There are numerous regulations that are at play in storage mapping today. That said, any business that manufactures or handles pharmaceuticals needs to ensure that they fully comply with the current GMP and GDP guidance.
In short, this means that the production, handling, and storage of all pharmaceutical products, as well as active pharmaceutical ingredients (APIs), must take place in validated facilities where qualified processes and equipment are in use.
Qualified processes mean providing proof that anything physically used in the manufacture, storage, or transportation of pharmaceuticals meets its design purpose fully.
This could be the room where a drug is produced, for example, or it could be the automated system that makes it. There again, qualification is needed to prove a storage facility or transportation container meets its intended usage criteria.
Only when a company has shown that each piece of physical equipment, including the facility where such equipment is used, is fit for purpose can it be said to be qualified.
To put it another way, when an item is used to produce, handle, or store a product made by a pharmaceutical company, a validation must be performed that demonstrates it functions within its design parameters. If just one element in the production, handling, storage, and delivery chain is not validated, then the process is not qualified.
Under GMP and GDP guidelines, validation relates to the entire process whereas qualification relates to every step within that process.
A simple way to think about the difference between validation and qualification is that anything physical that you could touch needs to be validated. The whole process, which consists of a well documented procedure resulting from these series of steps, is what needs to be qualified.
One can only validate what can be qualified, so long as a qualification is made at every step.
What does this mean in terms of warehouse mapping?
In the pharmaceutical industry, it means a great deal. For example, a customer product that needs to be maintained within a certain temperature range. Unless the machine making the product is qualified as functioning correctly within that range, the entire process cannot be validated.
Equally, the warehouse where the product will be stored must also be qualified to offer temperatures that lie within the same range. This is why storage mapping is essential given the aforementioned variations in temperature that can be expected within most storage facilities.
A qualification of a warehouse would begin with a definition of its intended purpose, such as to store products within a given temperature range. It would then continue to document how this has been evaluated and whether or not it meets its intended purpose.
As you can see, professional warehouse mapping is a key part of such documentation to ensure validation is maintained throughout the entire production and distribution processes of pharmaceutical products.
The Challenges Associated With Storage Mapping
When it comes to the crucial nature of temperature consistency in the pharmaceutical industry, qualifying an entire storage facility is necessary for a full production, storage, and distribution process to be validated. As such, qualifying every part of a warehouse or storage room is necessary, which will mean mapping it is required.
Why is this a challenge?
Essentially it comes down to the fact that the inherent design of a warehouse will mean that temperature inconsistencies are likely to occur, something that is the case regardless of any chilling equipment or air conditioning system you may have installed.
For instance, the areas closest to doorways will often be susceptible to the ambient temperature outside, especially when they are opened and closed frequently. Equally, zones of warehouses that are in close proximity to skylights and windows can suffer from greater fluctuations in temperature.
Furthermore, south-facing parts of a warehouse could warm up more than others from simple exposure of the outside wall to the sun's energy. As such, taking one or two readings from temperature data loggers placed around the facility is simply not enough.
What is needed is a full warehouse mapping procedure to meet best practices and avoid falling short of the regulations. Remember that measuring humidity as well as temperatures, in every part of a storage facility, will be needed to ensure the correct qualification documentation can be produced.
From temperature mapping to compliance in two months
Case study on the successful completion of a GMP-compliant temperature mapping in a highly automated Autostore of one of German's TOP online pharmacies.
Regulations Surrounding Warehouse Mapping
Remember that it is not just best practice to use data logging equipment that stores information gathered by calibrated sensors throughout a warehouse that makes storage mapping exercises so important these days. Without it, your organization would fall short of the current regulations that govern qualification and validation processes.
According to United States Pharmacopeia (USP), only by establishing a full temperature profile of a warehouse or production facility will allow it to be properly qualified.
USP's guidance states that observations of temperature variations in a storage facility should be made over a significant time period otherwise a meaningful temperature profile cannot be established.
In other words, a longer-term commitment to warehouse mapping needs to be maintained so that regulatory compliance can be ensured. Doing this in-house can, of course, be time consuming and a drain on resources which is why outsourcing it to a specialist in this field can be beneficial. Alternatively, ELPRO offers DIY remote thermal mapping kits as simple and user-friendly solutions. The collected data resulting from mapping facilities is sent to ELPRO. An assessment report is then generated that meets required for regulatory audits.
Warehouse mapping is an essential part of meeting the regulatory framework within which all life sciences companies operate. Of course, a fully validated process requires qualifications in all sorts of areas, not just storage mapping. However, it remains a crucial part of ensuring products reach the market without any critical concerns surrounding their provenance or quality.
There are many parts of a storage facility where mapping will help prove consistent temperatures are maintained or where further insulation measures may be required to ensure products are not compromised.