GMP Temperature Mapping of Cold Storage Areas
There’s an increased emphasis by regulators on the need to perform GMP temperature mapping on controlled temperature storage. PharmOut has the equipment and experienced professionals to help you achieve compliance in this area.
Why Perform GMP 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 doesn’t offer much advice on what this means in practice. Luckily, there are industry guidance documents that provide more information. The most useful is the UK Guidance on Wholesale Distribution Practice, 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).
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 this guidance is not strictly enforceable in many parts of the world, including Australia, it contains useful information about what regulators might expect when inspecting temperature-controlled storage areas.
GMP Temperature Mapping vs Calibration
Temperature-controlled storage areas in GMP facilities are usually continuously monitored by temperature probes. The temperature probes are routinely calibrated, which, you might think, is enough 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 within the temperature-controlled area.
A temperature mapping exercise is expected to collect the following information:
- The impact of interventions (door openings / power failures, etc.)
- Identification of hot and cold spots
- Variation of temperature at 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
Doing your own GMP temperature mapping can be a costly and time consuming exercise. With multiple probe locations required it can be expensive to purchase and maintain the necessary equipment. PharmOut can provide all the necessary equipment and calibration data for your temperature mapping exercise.
A temperature mapping exercise comprises four broad activities:
- Protocol development
- Trial execution
- Data analysis
PharmOut can perform all of these tasks as well as an ongoing mapping service after the initial protocol development.
PharmOut’s temperature monitoring equipment includes wireless capabilities which makes mapping large warehouses and cold rooms much simpler. Mapping performance can be checked in real-time, providing a huge advantage over the standard multiple battery-operated data logger approach. In-built reporting also provides consistency and certainty on data outputs.
If you would like a quote or to ask questions, please contact us at one of our offices around the world.
PharmOut have a set of controlled space design templates and Validation Protocols, i.e. IQ, OQ, and PQ templates for sale.