On May 1, 2024, the first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes:

  • USP General Chapter <1079.1> on Storage and Transportation of Investigational Drug Products
  • USP General Chapter <1079.2> on Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Product
  • USP General Chapter <1079.3> on Monitoring Devices – Time, Temperature, and Humidity

USP General Chapter <1079.4> provides guidance on the qualification of drug product storage areas with respect to temperature.  Although the focus of the General Chapter is on Temperature Mapping, the qualification principles could also be applied to mapping storage areas such as Stability Chambers for Relative Humidity.  It is noteworthy that the General Chapter is not applicable to manufacturers of active pharmaceutical ingredients (APIs), excipients, dietary supplements, and medical devices (except for drug-device combinations); however, manufacturers of drug products, radiopharmaceuticals, biological products, and biotechnological products are within the scope of this General Chapter.  Other drug product supply chain stakeholders are identified as within scope in the General Chapter as well.

As per the General Chapter, temperature mapping qualification studies should include:

  • An evaluation of the product storage area for factors that could potentially impact the operating temperature range, such as dimensions, design, HVAC, location, load pattern, exterior temperature variations, etc.
  • A rationale for temperature monitoring probe placement, taking into consideration any governing laws and procedures. Guidance is also provided on the minimum number of probes required for different storage area volumes.  Temperature probe placement maps are also provided in the General Chapter.
  • A sufficient number of calibrated monitoring devices programmed with the correct date and time.
  • A probe placement map based upon product storage locations, including a probe near the thermostat controller.
  • A temperature mapping study qualification protocol. The mapping studies must be of sufficient duration to capture workflow and system performance variations.  Seasonal temperature extremes should also be taken into consideration (coldest and hottest).  Load studies, open-closed door tests, and power on-off tests should also be conducted.
  • Mitigation strategies (if needed) to address any issues identified during the temperature mapping studies, including evaluation of short-term temperature excursions.
  • An approved final qualification report, which would include the temperature data, test results, and any deviations along with their resolution.
  • A rationale to determine when temperature remapping should occur, which should include significant changes in air-handling equipment, structural modifications to storage areas, changes in operational equipment, and significant changes in workflow.

The General Chapter does not address the frequency of periodic temperature mapping studies.  However, a risk assessment should be conducted by the firm to determine the appropriate frequency for conducting these studies.

USP General Chapter <1079.4> provides guidance on conducting temperature mapping studies to qualify that a drug product storage area is maintained within its operating temperature range.  The example temperature probe placement maps provided in the General Chapter are of significant interest as they give guidance on where probes should be placed for different size storage areas.

If you have any questions about how to apply the principals in USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas, Lachman can help guide you!  Please reach out to us at LCS@LachmanConsultants.com for a consultation.