GMP Temperature Mapping

There’s increased emphasis by regulators on compliance with GMP requirements for controlled temperature cold storage requirements. CiPharma has the equipment and experienced professionals to help you achieve compliance in this area.

Why Undertake temperature mapping?

Clause 3.19 of the PIC/S GMP guide states:

 “Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.

PIC/S advice on what this means is limited in practice. UK Guidance on Wholesale Distribution Practice provides industry guidance documents which offer more information, which states:

 “Large commercial refrigerators and walk-in cold rooms should be monitored with an electronic temperature-recording device that measures load temperature in one or more locations, depending on the size of the unit. Portable data-loggers that can be downloaded onto a computer may be used instead of a fixed device. Records should be checked daily. Internal air temperature distribution should be mapped on installation in the empty and full state and annually thereafter under conditions of normal use. Products should not be stored in areas shown by temperature mapping to present a risk (e.g. in the airflow from the refrigeration unit). Condensate from chillers should not be collected inside the unit.

All warehouses should be temperature mapped to determine the temperature distribution under extremes of external temperature. Mapping should be repeated every two to three years and after any significant modification to the premises, stock layout, or heating system.”

While not strictly enforceable in many parts of the world, this guidance contains useful information about what regulators may expect when inspecting temperature controlled storage areas.

Temperature Mapping vs Calibration

Temperature controlled storage areas in GMP facilities should be continuously monitored by temperature probes which are routinely calibrated to meet regulatory requirements.However temperature mapping is very different from calibration/routine monitoring. One of the key differences is the number of points the temperature is measured at in the temperature controlled area.

Temperature mapping exercise are expected to collect the following information:

  • The impact of interventions (door openings / power failures, etc.)
  • Identification of hot and cold spota
  • Variation of temperature across a single point
  • Temperature variation across the area
  • Length of time of any temperature excursions

To record all this information effectively, each temperature mapping exercise should be governed by a protocol detailing:

  • Selection of testing dates, with consideration to seasonal effects on the temperature controlled area
  • Number of probes to be used and justifications
  • Map of probe locations and justifications, including potential hot and cold spots
  • Duration of the exercise
  • What constitutes “normal use” and therefore levels of stock in the area that are to be used
  • Calibration requirements (pre and post)
  • Acceptable number of probe failures
  • Acceptable limits for temperature excursions (which may be product dependent).
  • Types of data to be generated
  • Reporting requirements
  • Consideration to acceptance criteria – not just within specified range, but variability across chamber and at each static point.

How to cost effectively meet your compliance obligations

Temperature mapping can be a costly process. With multiple probe locations required it can be expensive to purchase and maintain the necessary equipment.

CiPharma can provide all the necessary equipment and calibration data for your temperature mapping exercise, so that you don’t have to buy, maintain and know how to use it.

A temperature mapping exercise comprises four broad activities:

  • Protocol development
  • Trial execution
  • Data analysis
  • Reporting

CiPharma undertake all of these services, as well as an ongoing mapping service after initial protocol development.

CiPharma’s temperature monitoring service includes equipment with wireless capabilities, making mapping large warehouse and cold rooms much simpler. Mapping performance can be checked in real time, providing a real advantage over standard multiple battery operated data logger approaches. In-built reporting also provides consistency and certainty of data outputs.