Managing and Mapping Drug Storage, Temperature and Humidity Conditions
Product stability claims are based on studies conducted controlled temperature and humidity. Scientifically speaking, this means that the product is only considered to have maintained its quality if it is stored under similar controlled conditions. This is why facilities that warehouse or otherwise store product for later use need temperature mapping studies.
USP 38 General Chapter <1079> Good Storage and Distribution Practices for Drug Products states that optimal monitoring storage conditions shall be identified. This requirement also applies to third-party logistics providers (3PLs) seeking VAWD certification, according to the Drug Supply Chain Security Act (DSCSA). Compliance Team can help you make that determination.
Compliance Team begins with an evaluation of the facility layout. From there, we identify the study conditions and visit onsite to place our Part 11-compliant temperature sensors placed according to known environmental risk factors in your facility, according to a customized study protocol. We then author a report which evaluates the environmental extremes within the study area, informing you of the ideal environmental monitoring locations within your facility.
Through temperature mapping validation, organizations can demonstrate compliance with regulatory requirements, ensure product integrity, and maintain the reliability of temperature-sensitive goods throughout their storage lifecycle.
Additional data reported include the average sensor conditions, a map showing the sensor locations, a summary of local weather conditions, and calibration reports for the sensors. Studies are conducted in the summer and winter months to account for seasonal environmental fluctuations, and we provide a list of recommendations to facilitate future environmental improvements within the facility. In other words, our service removes the mental burden so you can concentrate on other things.
We work with you to verify that your facility satisfies the stated storage conditions needed to maintain a useful product life.