If a warehouse area is used to store raw materials, process intermediates, final product or process equipment, or if cGMP activity is performed in the area, then it is considered a cGMP warehouse and should be qualified.
The purpose of warehouse qualification is to determine the effect of environmental conditions on the temperature and relative humidity (RH) distribution within the storage area, and to ensure that adequate temperature and RH values are maintained during extreme heat and cold. Depending on the product stored in the warehouse, other conditions to consider may include lighting or air quality for clean or sterile areas. The mappings should initially be performed twice a year, once during the summer months and once during the winter months to reflect to worst case conditions for heat and cold, and then annually afterwards. The operating parameters should be determined through stability studies on the product stored within the warehouse area.
Additionally, the Mean Kinetic Temperature (MKT) should be calculated at each location where temperature is recorded. The calculated MKT is a reflection of how temperature fluctuations during storage, shipping and handling will affect the shelf life of product, and is calculated by Ellab software per USP chapter no. 1151 and ICH norm no. Q1A (R2) page 15.
A secondary purpose of the mapping is to determine the areas of highest and lowest temperature and RH values, or the “hot” and “cold” spots. These are the locations where permanent monitoring probes are installed, typically in addition to where thermostats are located. The qualification mapping will ensure that the HVAC system is performing as intended as well.
Ellab offers several systems that can be used to execute a warehouse qualification. The LAB temperature/RH wireless sensors are ideal for large areas that wired dataloggers may be unfit to map. If a wired system is preferred, the compact E-Val Pro system can support up to 40 input channels per module and utilizes the ValSuite™ Pro software, which allows for both wireless and wired systems to be used simultaneously. Our trained validation staff can support your warehouse qualification from protocol development and review, through execution and final report delivery.
Standards and Guidelines
- USP 1079 – Specifies various factors that may affect temperature distribution and should be considered, including airflow and average use. Another consideration is that the data collection period should be long enough to capture average warehouse activity during the week/weekend. Also requires temperature sensors to be calibrated to NIST traceable standards.
- FDA 21CFR211.142 – Specifies operating conditions for temperature, RH and light and requires quarantine of drug products before final release.