So you’ve written your temperature mapping protocol and completed your study. Now you’re ready to write your temperature mapping report. This final document should contain compiled data, storage conditions, calibration and post-calibration requirements, and data analysis.
Once the study is over, download the data from the iMiniUSB pdf by connecting the units to your computer. Save the original PDF files on a CD. Keep this CD with the original copy of your protocol, signed and documented, for future audits. Also, make sure to write down the name of the software used to retrieve the data.
Once this is done, export data into an Excel spreadsheet for additional analysis. However, keep in mind that exporting data to Excel does not maintain the integrity of the data and is considered transcription. This is why a second person must verify all data transcription and calculations to ensure the data has not been tampered with.
Pro Tip: The reports must be compliant to PIC/S GMP Annex 11 and 21 CFR Part 11 requirements.
Evaluate your Storage Conditions
Numerous regulatory authorities suggest using the mean kinetic temperature (MKT) for establishing profiles of storage facilities. However, they do not reference the use of MKT for determining the environmental effects (i.e. light, humidity and temperature) during distribution.
The USP states that determining the ability of pharmaceutical products to maintain their Pharmacopeia qualities through distribution may include:
- Use of ICH stability studies
- Temperature cycling studies
- Stability shipping studies
- Ongoing regulatory stability commitment studies
- Market experience portfolios
- Product labeling commitments
Calibration and Post-Calibration Requirements
Calibration is a common concern in pharmaceutical activities involving instruments, including data loggers. When collecting data, always use instruments calibrated using the appropriate tolerance range for the measurements. The calibration should be NIST traceable and consistent with Good Documentation Practices (GDPs).
You should also perform a post-calibration after the study to ensure they are still operating within original specifications. The HPRA recommends performing post-calibration on a minimum of 10% of data loggers following a temperature mapping. Only single-use devices provided with a calibration certificate from the manufacturer are exempted.
Data Analysis and Temperature Mapping Report
Your Excel data and graphs become an integral part of your temperature mapping report, as they identify any undesirable temperature patterns. If any problems arise from the mapping study, you can take a wide range of measures to address them:
- Remove products from specific problematic areas (such as hot spots near ceilings)
- Change work habits (such as keeping doors open or closed)
- Change racking or shelving configuration
- Change the location of heating or air conditioning devices
The analysis should also identify the most vulnerable spots in the storage areas, commonly known as the hot and cold spots. Once these locations have been identified, you should install real-time monitoring sensors in these areas to provide added reassurance that the conditions match the product storage specifications at all times.
A continuous record is vital in order to reach regulatory compliance in cold chain. Indeed, a detailed record comes in handy in many instances, particularly when regulatory authorities carry out inquiries or audits. From a legal standpoint, you need to retain all records for a specific period of time and make sure they are readily retrievable.
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