Thursday, 16 March 2023 14.00 - 16.00 h
The United States Pharmacopeia (USP) continues its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.
The current plan for the series is as follows:
Chapters <1079> and <1079.2> are already effective. For <1079.3>, a draft is available for comments.
Chapter <1079> applies to organizations and individuals involved in the storage and transportation of drug products. It describes a risk-based approach to the storage and transportation of finished drug products and risk mitigation strategies.
The chapter was formerly entitled "Good Storage and Distribution Practices for Drug Products". There was a comprehensively revised version (valid from December 2020 to January 2021) with the title already changed. The current version of the chapter is official as of February 1, 2021. In the Pharmacopeial Forum, PF 48(3), a proposal was published with the deadline for submitting comments on July 31, 2022. In this case, it is only a minor revision to remove an inappropriate General Notice reference without any changes in content.
Chapter <1079.2> addresses the utility and application of mean kinetic temperature (MKT) for the evaluation of temperature excursion in controlled room temperature (CRT) and controlled cold temperature (CCT) products.
<1079.3> is a new chapter. It was published in the Pharmacopeial Forum, PF 48(4), in July 2022. The deadline for submitting comments is September 30, 2022. At the same time, it was proposed to omit <1118> Monitoring Devices—Time, Temperature, and Humidity, as the information will be included in the new general chapter <1079.3>.
Chapter <1079.3> provides background information about the science and technology of temperature and humidity monitoring over time. It also describes the available technologies and performance characteristics and provides recommendations for qualifying performance.
<1079.4> is also a new chapter, which was first published for comments in the Pharmacopeial Forum, PF 48(5), in September 2022.
For further information, please also see the following articles in our news archive:
The draft versions of all proposed new chapters are available in PF Online. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)