The GxP Compliance Endeavour
Achieving compliance for your environmentally controlled storage facility can be a challenging and demanding task, requiring significant investment of both time and resources. Temperature and/or humidity mapping as well as facility monitoring are crucial to ensuring appropriate storage procedures for pharmaceuticals, and good practice for pharmaceutical products which recommends regular mapping in all types of warehouses.
We are aware of the crucial obligation that guarantees the integrity and safety of your products and that's precisely where our Mapping Services can provide the valuable assistance you need.
With our innovative GxP Mapping procedure, obtaining a compliant facility can be significantly simplified. This is especially helpful if you have to replace systems or equipment repeatedly, as the process can be complicated and time-consuming. The EUCA service team can assist you with this process, making it more efficient and streamlined for your operations.
Temperature & Humidity: What's the fuss?
Maintaining appropriate temperature and humidity conditions is crucial for the effectiveness of pharmaceutical products. While coastal regions may require stricter humidity controls, in-land regions may not need as much emphasis on it since the atmospheric humidity is not as high. However, both temperature and humidity exposure remain the primary factors that could render scheduled medicines and equipment ineffective.
Why We Perform Summer & Winter Mapping
Determining points of failure is essential to identify optimal locations for prolonged storage of sensitive medicines or medical equipment. These spots should be determined seasonally as they can vary greatly between summer and winter. It is important to analyse overall high and low trends, rather than just the highest and lowest temperatures, to get an accurate understanding of the situation. Additionally, average values can help confirm true hot and cold spots.
Identifying Hot and Cold Spots
The 7-day Mapping Procedure
The first step is a complimentary site-survey which we will book with the service team. Our team of GxP specialists will guide you through the process of establishing the URS (User Requirement Specifications), making the initiation of the mapping is as convenient and efficient as possible.
Following our site assessment, the design is detailed and is generated to fulfil and implement the procedure required to take the next steps. The purpose of mapping is to show uniformity of temperature across the storage facility, by placing temperature sensors periodically in areas that are most likely to show fluctuations, we can ensure that we the mapping procedure meets the necessary standards and requirements.
The system used is crucial for demonstrating that the performance parameters of your equipment conform to the design parameters that were originally specified. Most mapping procedures will run consecutively for 7-days, during this time we check and verify the temperature and humidity, ensuring that they meet the necessary requirements.
"We meticulously document and verify the accuracy and precision of these parameters to ensure that they conform to the necessary standards."
After the 7-days we start analysing the data to determine the overall stability of the storage area and identify the risks that could occur, by comparing the measured results against the SAHPRA acceptance criteria to compile a report which includes visual data.
A Mapping Summary Report is presented to provide you with all the critical information you need to make informed decisions about your facility's controlled storage environment and the sensitive goods being housed. With the utilization of mapping, you can enhance your operational efficiency, allowing you to focus on other essential aspects of your facility's operations.
Head over to our EUCA Support Page to learn more about our other services and how we can help your facility reach your goal of compliance and sustainability. Let us help you take care of your environment so that you can concentrate on running your facility effectively.
Book Your 2023 Winter Mapping Site Survey Today!
