[Stability Testing related News – vol.62]

◆  Final Concept Paper: Targeted Revisions of the ICH Stability Guideline Series (Guidelines ICH Q1A-F, ICH Q5C) (15-Nov-22 ICH)

Final Concept Paper on Targeted Revisions of the ICH Stability Guideline Series (Guidelines ICH Q1A-F, ICH Q5C) was endorsed by the Management Committee on 15 November 2022.

Revision of the ICH Stability Guideline Series Q1A-F and Q5C is recommended to
a) streamline the series by combining the various guidelines into a single guideline focused on core stability principles;
b) promote harmonised interpretation by addressing potential gaps and areas of ambiguity;
c) address additional technical issues, including relevant stability strategies and innovative tools that strengthen the
application of risk management; and
d) consider inclusion of new topics, such as stability considerations for advanced therapies.

The informal working group proposes to establish these updates through the Revision procedure. The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core principles on stability recommendations and to address product type1 specific recommendations, as required.

◆  Temperature Mapping for the Qualification of Storage Areas (15-Nov-22 ECA)

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled “The Use of Temperature Mapping for the Qualification of Storage Areas for the Proper Temperature Storage of Drug Products” was published. It was written by Chris Anderson, Desmond G. Hunt, and Robert Seevers.

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

Content of the Article

In the Abstract, the author team says that the “article describes the use of temperature mapping as a process to qualify storage areas to maintain temperature for the storage of drugs, which is an effective strategy to identify risks as part of a quality management system.”

The article starts with an Introduction. The authors point out that maintaining temperature during storage is an important aspect to make sure that the safety, efficacy, and expiry of drugs are kept. This, of course, includes avoiding temperature excursions during storage. To evaluate if storage areas can adequately maintain the appropriate temperature, temperature mapping studies are necessary.

The following sub-chapter of the article (Developing a Strategy and Protocol for Temperature Mapping) lists what should be recorded when evaluating the number of temperature monitoring devices needed and where to place them.

The main part of the article, Determining the Number and Placement of Temperature Monitoring Devices, gives recommendations on the minimum number of probes/temperature monitoring devices and placement. This is illustrated by several figures.

The following relatively short subsections of the stimuli article deal with the following topics:

  • Temperature Monitoring Devices
  • Planning und Execution
  • Evaluating Data
  • Mitigation Strategies
  • Documentation
  • Following-up Mapping Frequency Strategy

The article ends with a short Conclusion saying that it “highlights the use of temperature mapping as a method to evaluate and qualify drug storage areas, in order to maintain product integrity from a temperature perspective. Temperature mapping can be a valuable strategy to identify risks and to demonstrate the effectiveness of risk mitigation strategies.”

The article contains several references to USP chapters or drafts that we have also reported on over the past several months:

  • USP <1079> Series of Chapters on Good Storage and Distribution Practices, in particular
    – <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
  • USP General Chapter <659> Packaging and Storage Requirements

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