GDP in the US: New USP Chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5).

The draft is available via the USP Website Access Point. Commenting is open from 01 September to 30 November 2022.

Background

The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

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.

In the briefing notes of the new chapter, the following is summarized: "The extent of physicochemical degradation of drug products depends on factors such as product stability, which includes how a product is stored. Storage and handling areas need to maintain labeled temperature ranges to ensure product efficacy and expiry. The technique used to evaluate the effectiveness of drug product storage areas to maintain temperature is referred to as temperature mapping. Proper use of temperature mapping can help determine whether storage areas can maintain the appropriate temperatures as well as any areas that may require mitigation. This proposed new general chapter focuses on the qualification of storage areas to maintain temperature and provide best practices as it relates to temperature mapping."

Content of the New Chapter

The new chapter is divided into the following main sections:

• 1. Introduction
• 2. Scope
• 3. Evaluate product storage area
• 4. Obtain monitoring devices
• 5. Develop probe placement map based on evaluation
• 6. Schedule and execute mapping
• 7. Determine migration strategies (if needed)
• 8. Complete report for approval
• 9. Frequency of temperature mapping
• 10. Conclusion

Subchapter 3.1 (Temperature monitoring device probe placement) gives detailed examples and recommendations on how to establish the number of temperature probes to be used. This is illustrated with a number of figures.

To Whom does the New Chapter Apply

Documents in PF Online are not official. They may be revised before coming into force or may never become official.

Nevertheless, the following can be stated: According to the scope of the new chapter, the text "applies to every link in the supply chain from the manufacturer through any entity that transports or stores a finished drug product, with the sole exception of the patient." These include, for example

• wholesale distributors,
• third-party logistics providers,
• freight forwarders,
• organizations involved in storage
• road, rail, sea, and/or air transport services,
• mail distributors that offer expedited or controlled-temperature shipping services,

but also many other stakeholders.