Warehouse Temperature Mapping According to the American Pharmacopeia recommendations USP<1079>

What is USP ?

The “United States Pharmacopeia” (USP) is a non-governmental, US Health organization defining standards in order to improve public health in the United States. USP's standards are recognized and used in more than 130 countries around the globe.

What is the USP General chapter <1079> “Good storage and shipping practices” ?

The USP<1079> defines the requirements to improve preservation of pharmaceutical products, from the manufacturer to the final user. This standard highlights the need for environmental controls to maintain the quality of medicines. Temperature is one of the most important parameters to be monitored. Indeed, medicines can only be stored, handled and transported in accordance with pre-determined temperatures. 

 

What does USP guidance actually say?

"Operational and performance testing should be parts of a formal qualification protocol /.../ Observation of the temperature variations in a warehouse should be made over a period of time to establish a meaningful temperature profile, including the temperature variations and conditions in different parts of the warehouse /.../ Temperature profiling should be conducted in both summer and winter and the temperature profile report should provide recommendations."

 

What is the scope of this norm?

This norm is applied to any activity of storage or transport of pharmaceutical products.

 

How could you comply with this norm?

JRI, expert in measuring systems, has developed environmental monitoring solutions to answer these requirements.