Creating a Validation Plan 101
Ensure Compliance by Performing Warehouse Mapping
Pharmaceutical, biological and medical device products require controlled environmental storage conditions. More specifically, Good Manufacturing Practice (GMP) requirements for compliance include 21 CFR Part 820 for medical devices, 21 CFR Part 211 for drug products and ICH Q7 guidance for Active Pharmaceutical Ingredients (APIs). Masy has several solutions that can help you safeguard your items and stay in compliance. Our experts have outlined key considerations when creating a validation plan for your warehouse mapping study.
We know degradation can occur when the storage environment of the product exceeds the range of safe conditions of that product. For example, some pharmaceutical materials need to be stored at ambient temperature to preserve the potency of the product. If the temperature of the storage environment goes outside that range, damage to the pharmaceutical material may occur. To help ensure ideal conditions, thermal mapping of all storage areas is required to assess the environmental parameters of the stored pharmaceutical materials. Analyzing these conditions and exposure variables are especially important for warehouse storage due to seasonal climate fluctuation.
Our validation experts have developed proven best practices for mapping any storage area and are especially qualified to meet strict GMP requirements. The first step for any size storage facility is developing a successful validation plan. Here’s a foundational guide when creating that plan.
Validation Plan- 4 Critical Components
- Assessing the Storage Envelope
A Validation Plan starts with assessing the storage envelope which involves two key elements. First, you must determine the actual storage requirements for the product or materials. This factors in all compliance considerations, including acceptable conditions for temperature and humidity.
The second element is more complex. Anything that might impact the range you want to control must be identified and evaluated. A good starting point is to examine the specific materials plan for the space. For example, think in terms of: a. where the materials are being stored, b. vacant areas planned for future storage, c. vacant areas that will remain vacant and not be used for storage. Temperature can be impacted by lighting fixtures, equipment that emits heat, windows, and sunlight which often act as a heat source. Where might these factors impact your environment?
Next, evaluate the HVAC system that controls the temperature and/or the humidity as well as the locations of the supply and the return points. Take note of these locations relative to the material storage locations—specifically the arrangement, the height, and the density of the racking. Racking distance from the walls plays a pivotal role because those walls can often be warmer or colder than the air in the space that's being controlled. Note that adjacent storage areas (with a shared wall) that are maintained at a different temperature can also contribute to heating or cooling your side of the space.
It's important to also identify anything (structures, product, equipment, etc.) that can impede airflow throughout the warehouse. A reliable environment is very dependent on consistent air movement to maintain the temperature and humidity conditions. Blocked airflow has the potential to create troublesome hot or cold spots.
Consideration of the factors above should help determine where sensors should be placed for qualification when you execute the plan. Therefore, this assessment of the storage envelope is essential to a successful study.
- Study Length
Industry best practices recommend that a warehouse mapping study spans seven days. This duration is designed to present data for normal activity during the week as well as slower activity or downtime over the weekend.
Mapping studies need to capture normal operation of the storage area as well as low foot traffic days to get the full range of temperature variations. Temperature excursions, such as opening a door, excessive foot traffic, product movement, and daily HVAC operation, can occur during normal operation events. Warehouse mapping studies should run for a minimum of seven consecutive days to demonstrate area uniformity during both weekdays and weekends.
- Seasonal Mapping
During the initial performance mapping of the warehouse, it is recommended to perform the mapping in the hottest and coldest seasonal months if the warehouse has walls or a ceiling that is exterior to the building. If the warehouse is contained within the middle of a facility with no exterior wall or ceiling, only one performance mapping is required initially. Requalification should be performed periodically as defined by your organization.
- Sensors and Experience
As the saying goes, “you want the right tool for the job,” and of course you want experienced people using those tools. It is extremely important that you have the correct sensors with the correct tolerances to map a warehouse. In large spaces, for example, a wireless portable logger has several advantages. It is small, unobtrusive and doesn't require a plug-in power source. The sensors must provide accurate readings (whether mapping for temperature or for temperature and relative humidity) to give you the utmost assurance that the environment is fit for the valuable product you are storing. It is equally important to be sure that each sensor is calibrated and traceable to NIST or equivalent prior to the mapping study as well as verified after the mapping had completed.
Masy recommends that you carefully choose the sensor type that will be used for mapping. Consider the data you want to capture in relation to the physical design because the design might influence how quickly it responds to changing conditions. Sensors should be placed in locations to identify at risk temperature areas during mapping.
It can be challenging to navigate the numerous variables involved with warehouse mapping. Every project is unique. Our team has validated thousands of storage areas and uses that experience to pass on efficiencies and accuracy with every mapping study.
Thermal mapping of warehouse storage areas is essential to assess the environmental conditions that stored products will experience. The results of the study allow you to better understand the environment in which you plan to store your valuable product(s) within. We have outlined several key considerations when creating a validation plan and steps to take prior to the mapping study that we hope you find helpful. For a deeper dive into the importance of warehouse mapping and how to execute successfully, download our whitepaper, “Successful Warehouse Mapping.”