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

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

The United States Pharmacopeia (USP) General Chapter <1118> Monitoring Devices—Time, Temperature, and Humidity will be omitted on 01 December 2023. In this context, the USP identified other Chapters referring to General Chapter <1118> that will be impacted by this omission.

The <1079> Series

The USP <1079> series consists of different chapters around the topic of GDP. 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

General Chapters Affected by Omission to <1118>

In a so-called Notice of Intent to Revise published on 28 April 2023, a list of General Chapters that will be modified was published. According to this, three chapters, namely <1079>, <1079.1> and <1079.2> are affected. USP NF 2023, Issue 3 was given as the target publication date. Thus, the chapters were updated on 01 June 2023 and will become official on 01 December 2023.

The draft versions of all proposed new chapters are available in PF Online via the USP Access Point. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)