The United States Pharmacopeia (USP) is making important changes to series of chapters on Good Storage and Distribution Practices <1079> that will impact risk mitigation strategies for storage and transportation of finished pharmaceuticals.
This chapter focuses on packaging, storage, and transportation processes that maintain drug product quality and supply chain integrity. The proposed revision identifies common risks in the storage and transportation of drug products and recommends appropriate mitigation strategies.
The new USP <1079> changes are significant and highlight the need for companies who will store, handle or transport products with label temperature requirements to meet a thorough Quality Management System (QMS). USP <1079> defines good storage and distribution practices for temperature sensitive drugs during all stages of the cold chain.
The existing chapter is titled “Good Storage and Distribution for Drug Products.” The new proposed chapter title will be – “Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.”
The <1079> Series
The current plan for the expanded series is as follows:
- Good Storage and Distribution Practices for Drug Products 〈1079〉 (Future title: Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products)
- Storage and Transportation of Investigational Drug Products 〈1〉
- Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products 〈2〉
- Monitoring Devices—Time, Temperature, and Humidity 〈1118〉 (Future number: 〈3〉)
- Qualification of Storage Areas 〈4〉
- Qualification of Shipping Systems 〈5〉
- Transport Route Profiling Qualification 〈6〉
- Information Systems for Distribution Validation/Verification Studies 〈7〉
Chapters <1079> and <1079.2> are already effective. For <1079.3>, a draft is available for comments.
The sub-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.
Is a new sub-chapter. It 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.
Sub-chapter <1118> “Monitoring Devices—Time, Temperature, and Humidity” will be omitted, as the information will be included in the new sub-chapter <1079.3>.
<1079.4> is also a new chapter, which was first published for comments in the Pharmacopeial Forum, PF 48(5), in September 2022.
The draft versions of all proposed new chapters are available in PF Online.