Audit-Proof Thermal Mapping: A Global GxP Playbook Webinar Recap

WHO has great guidance for warehouses as they give specific heights and distances. ISPE has helpful guidance on mapping for equipment. For up to two cubic meters, you typically need nine loggers plus one, and up to 20 cubic meters it’s typically 15 plus one. 

Yes, they are compliant and have specific validation packages that come with our GxP documentation that show their compliance.

There are no additional fees for using the Mapping Suite whether using cellular, Wi-Fi, or Ethernet options. The subscription fee covers everything in the kit.

Even in a non-pharmaceutical production environment, temperature and humidity mapping can provide significant value when equipment performance, process stability, or product quality is sensitive to environmental conditions.
Continuous monitoring allows you to track environmental conditions over time, but it does not necessarily demonstrate that temperature and humidity are uniform throughout the production area.
An initial mapping study can help identify potential hot spots, cold spots, humidity variations, and the most representative or critical locations for permanent monitoring sensors.
Based on the mapping results and a documented risk assessment, ongoing monitoring may then be sufficient to maintain environmental control, provided that the operating conditions remain stable.
In summary, mapping helps determine where to monitor, while continuous monitoring confirms that environmental conditions remain under control over time.

A documented risk assessment should demonstrate that winter conditions do not introduce additional risks, such as cold spots, temperature stratification, HVAC operating mode changes, or relative humidity variations.
Ideally, this assessment should be supported by historical temperature and humidity monitoring data, previous seasonal mapping results, and an evaluation of the warehouse’s HVAC performance.
If the available evidence demonstrates that summer represents the worst-case condition and winter does not introduce any additional risks, a summer-only seasonal mapping strategy may be scientifically justified, subject to applicable regulatory requirements and Quality Assurance approval.

While there’s no side-by-side option in the software, you can compare two reports generated from the platform to see the differences there.

Typical challenges faced are assembling the data and analyzing the data in a compliant manner. As most data from dataloggers are downloaded in single csv type file which must be collated with other data sets from other sheets. 
Then you must analyze all that data in a compliant manner. This means the spreadsheets must be kept secure, have the appropriate controls, and the security and calculations must be validated. This is also necessary for any computerized system/software that you use to handle this analysis. If there are issues with data, meaning missing data from failed dataloggers, this can also create challenges in meeting acceptance criteria or validity of the results. 

If you can show why certain aspects of your temperature are affecting a process and it’s making it more inefficient, those numbers can help you give arguments as to why you need to monitor more and do particular studies.

Deviations are handled through separate deviation reports that track any type of failure (procedural, equipment, acceptance criteria). Each deviation report identifies the deviation event, the investigation, impact, and makes a conclusion for the deviation event. This is all documented and reviewed/approved. Each deviation report is logged into the mapping study to keep track of each event.

Mapping Suite keeps a permanent, read-only audit trail that no user can edit or delete. It records user logins and session expiry; studies and spaces being created and edited; schematics being created and loggers placed on them; logger registration; loggers being assigned to or removed from a study; and report generation. Each entry shows:
– the date and time
– the full name of the user (or the system) that triggered it
– the event type
– a description, including any user comments
– the affected study and space
– for edits, the old and new values
You can export the audit trail to CSV for a validation package or an audit response. User accounts, authentication and access controls come from the validated DicksonOne platform, and Mapping Suite is designed to meet 21 CFR Part 11.

There are no specific guidelines that give you an exact time frame for frequency of stability chamber re-mapping. This all depends on the risk assessment for the chamber and the products that it holds.  Therefore, frequency can range from annually or every 2 to 5 years. In the ISPE Controlled Temperature Chamber Good Practice Guide, the interval itself is something you determine based on the performance, history, and criticality of the chamber.

There is no single worldwide regulation governing temperature mapping for pharmaceutical products intended for export. The applicable requirements depend on the destination market, the product’s approved storage conditions, and the relevant GMP/GDP regulations. International references such as WHO guidelines, EU GDP guidelines, and applicable US FDA requirements provide a framework for ensuring appropriate storage conditions.
From a temperature mapping perspective, the key objective remains the same: to demonstrate that the warehouse can maintain the required storage conditions, regardless of the final destination of the products.

You map your facility to identify hot and cold spots, and you do this in different extreme seasons (e.g. winter and summer).

Stability studies in terms of mapping demonstrate that you are kept in that specific environment for your stability study. You need to show that you’ve maintained it in a specific condition, and the specific environment is “validated” to be what it is for your stability study.

Mapping Suite is built to map and qualify spaces. To qualify a shipping vehicle, container or packout, you set it up as a Shipment space and run a study against your acceptance limits. The study graph plots every reading against the high and low limits, and the report lists each logger that went out of range. For ongoing monitoring of live shipments, a dedicated in-transit monitoring solution is the better fit.

Schedule M compliance depends on the manufacturer’s whole quality system: its mapping protocol, its acceptance criteria and its QA approval. No mapping report can make a site compliant on its own. Mapping Suite supplies the evidence a mapping study needs:
– time-synchronized data from every logger
– documented logger placement
– defined acceptance limits
– minimum, maximum, mean and MKT for each location
– a full raw data export
– signature and initial fields
– an audit trail designed for 21 CFR Part 11
We defined its requirements against WHO TRS 961 Annex 9, ISPE guidance and USP <1079>. We’d suggest your QA team review a sample report against your own SOPs.

Yes. Mapping Suite calculates MKT for every logger automatically, using the standard Arrhenius-based equation with an activation energy of 83.144 kJ/mol. For each logger, the report shows the minimum, maximum, mean and MKT. It shades the highest mean and MKT red and the lowest blue, so hot and cold spots stand out right away.
An excursion shows up on the temperature graph against your limits, and the summary table lists every logger outside the temperature range. Loggers missing more than 1% of their readings are left out of the graphs and calculations and flagged in the tables, so gaps can’t skew the results. The full CSV export lets you do your own impact analysis.

In Rwanda, but also in any other country, acceptable temperature and relative humidity limits depend on the products being stored and their approved storage conditions, rather than on the country itself.
For example, some pharmaceutical products require storage between 15°C and 25°C, while some products typically require 2°C to 8°C. Relative humidity limits should be established based on product sensitivity, manufacturer requirements, and applicable regulations. FDA Good Storage and Distribution Practices guidelines do not establish a universal numerical tolerance for temperature and humidity mapping.
Acceptance limits must be defined based on the approved storage conditions of the products, supported by a documented risk assessment.