GDP in the US: The USP <1079> Series of Chapters on Good Storage and Distribution Practices

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

The United States Pharmacopeia (USP) continues its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

The <1079> Series

The current plan for the series is as follows:

• <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• <1079.1> Storage and Transportation of Investigational Drug Products
• <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
• <1079.3> Monitoring Devices—Time, Temperature, and Humidity
• <1079.4> Temperature Mapping for the Qualification of Storage Areas
• <1079.5> Qualification of Shipping Systems
• <1079.6> Transport Route Profiling Qualification
• <1079.7> Information Systems for Distribution Validation/Verification Studies

Chapters <1079> and <1079.2> are already effective. For <1079.3>, a draft is available for comments.

USP <1079>

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.

USP <1079.2>

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.

USP <1079.3>

<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.

USP <1079.4>

<1079.4> is also a new chapter, which was first published for comments in the Pharmacopeial Forum, PF 48(5), in September 2022.

Further Information

For further information, please also see the following articles in our news archive:

• GDP in the US: New USP Chapter <1079.3> on Devices for Temperature and Humidity Monitoring over Time
• GDP-relevant Documents from FDA and USP Currently in Commenting Process
• USP revises Storage and Transport Chapters

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.)