GDP in the US: New USP Chapter <1079.3> on Devices for Temperature and Humidity Monitoring over Time

Recommendation

Tuesday, 26 September 2023 9 .00 - 17.30 h

GDP Audits - Live Online Training
How to Audit Logistics Service Providers

In the Pharmacopeial Forum, PF 48(4), a proposal for a new USP chapter <1079.3> Monitoring Devices—Time, Temperature, and Humidity, providing background information about the science and technology of temperature and humidity monitoring over time, has been published for comments. At the same time, it is proposed to omit <1118> Monitoring Devices—Time, Temperature, and Humidity, as the information will be included in the new general chapter <1079.3>.

A chapter numbered below 1000 becomes applicable and compendially required respect where it is referenced in a monograph or another applicable general chapter numbered below 1000 or in general notices. General chapters numbered 1000 to 1999 are for informational purposes only. They are considered interpretive and are intended to provide information on, give definition to, or describe a particular subject.

According to the USP, the new proposal for chapter <1079.3> "describes the available technologies and performance characteristics and provides recommendations for qualifying performance. [...] This chapter is being developed and <1118> is being omitted to continue the effort to build out the <1079> series of chapters on Good Storage and Distribution Practices."

The new chapter is divided into the following main sections:

• Introduction
• Temperature-measurement devices
• Electronic time-temperature history recorders
• Chemical temperature indicators
• Relative humidity measurement technologies
• Calibration of temperature- and humidity-monitoring devices
• The use of historical temperature data
• Standards for temperature and humidity data reporting
• References

The draft of the proposed new chapter <1079.3> is available at the USP Website Access Point. (Please note: a one-time registration is required to access the Pharmacopeial Forum.) The deadline for submitting comments is September 30, 2022.