Temperature mapping is required to determine the suitability of storage areas and transport equipment for storing and transporting drugs and vaccines. Conducting these studies is an essential part of GDP and GMP approvals and helps companies comply with regulatory requirements. In this article, we discuss when temperature mapping is necessary and how it helps ensure regulatory compliance and product quality assurance.
When is temperature mapping necessary?
Even though temperature mapping is mandatory, it offers insights from which you can benefit directly.
When is temperature mapping mandatory?
Temperature mapping is mandatory when commissioning new rooms and transport equipment. Whether it is a warehouse, cold room, truck or cooler, a mapping determines whether the temperature distribution meets the requirements for storing and transporting drugs and vaccines. These studies are also required for changes that may affect temperature stability, such as modifications to insulation, ventilation or layout of existing facilities. We call this initial mapping a commissioning or qualification mapping.
Why is seasonal mapping necessary?
Seasonal mappings, such as summer and winter studies, are essential to understanding the impact of temperature differences throughout the year. These additional mappings help companies evaluate the performance of spaces and transportation equipment under extreme conditions. Through these additional studies, critical issues can be better identified and addressed, which is critical to ensuring stable temperature performance.
How does temperature mapping contribute to quality assurance?
Temperature mapping goes beyond a regulatory requirement. It provides insights that allow companies to ensure the integrity of temperature-sensitive products. Regular mapping and additional tests, such as opening doors at cold rooms or turning off air conditioning systems, help identify hot and cold spots and critical control points. This process supports companies in the pharmaceutical industry in complying with regulations and optimizing their storage and transportation methods.
