Guidelines for risk-based temperature mapping in GxP

Risk-based temperature mapping is no longer just a best practice, it is becoming a GxP industry standard – and for good reason. Learn how to efficiently apply a risk-based approach to your next mapping.

Regulatory bodies, such as the FDA and EMA, and guidance organizations, like WHO and ISPE, are increasingly advocating for a risk-based approach to temperature mapping, emphasizing efficiency and scientific justification over rigid, one-size-fits-all methods.

But how do you apply a risk-based approach to temperature mapping? What should a risk assessment for temperature mapping entail? And how do you define data logger placement based on risk zones?

This article provides practical guidelines for applying a risk-based temperature mapping strategy in GxP.

The article goes through:

• The differences between risk-based and non-risk-based mapping
• Why to take a risk-based approach to temperature mapping
• How to conduct risk-based temperature mapping
• Guidelines for developing a risk assessment for mapping

Risk-based vs. non-risk-based temperature mapping: What is the difference?

Temperature mapping is a critical component of GxP compliance, ensuring that storage environments for pharmaceuticals, biotech products, and other regulated goods maintain consistent, controlled conditions.

The key difference between a risk-based and non-risk-based mapping approach lies in strategy and efficiency.

• Non-risk-based mapping rigidly follows predefined guidelines, placing sensors in a fixed grid pattern. It often results in over-monitoring, excessive costs, and unnecessary complexity.
• Risk-based mapping prioritizes critical zones based on a structured risk assessment of the specific facility or temperature-controlled unit. Sensors are placed in high-risk areas, such as near doors, HVAC systems, or known temperature fluctuation points, ensuring optimized compliance with fewer resources.

The key differences

The specific approach depends on the circumstances – from guidelines to facility layout – but simply put, these are the key differences between the non-risk-based and the risk-based mapping approach.

Why take a risk-based approach to temperature mapping?

A risk-based approach shifts the focus from applying generic guidelines to identifying and targeting actual risks within your specific storage conditions. Instead of placing sensors in fixed positions and conducting full mapping studies at fixed intervals, risk-based mapping ensures that critical zones are monitored strategically and continuously.

By following a risk-based methodology, organizations can:

• Improve regulatory confidence by providing clear, data-driven justifications for mapping decisions and focusing on real operational risks.
• Reduce unnecessary costs by reducing the needed number of data loggers and avoiding redundant tests.

Also see: “How many data loggers do you need for temperature mapping in GxP?”

How to apply a risk-based approach to temperature mapping?

Learn the guidelines for developing a risk assessment for temperature mapping, developing your mapping protocol, and much more.

1. Start with a structured risk assessment for your temperature mapping

A risk-based temperature mapping strategy begins with a comprehensive risk assessment to identify high-risk areas that require continuous monitoring. This assessment should evaluate:

• Compliance risks: Regulatory requirements such as hot and cold spot identification, periodic validation, and mapping frequency
• Technical risks: Factors like ventilation design, external temperature fluctuations, and heat-generating equipment
• Operational risks: Real-world usage patterns, including door opening frequency, storage layout, and workflow disruptions

Best practice: Document all risk assessments in a structured format to provide a clear audit trail and justify sensor placement and mapping frequency.

2. Define a mapping protocol based on identified risks

Your temperature mapping protocol is the foundation of compliance and should align with regulatory expectations while remaining flexible to operational needs. A GxP-compliant mapping protocol should include:

• The rationale for sensor placement (e.g., near doors, HVAC blowouts, or known cold spots)
• Justifications for excluding certain tests (e.g., power failure studies may not be needed if backup systems are in place)
• Specific testing scenarios, such as door-opening studies and seasonal mappings

Example: If a facility is inside a climate-controlled warehouse, the protocol should document why seasonal mapping may not be required, demonstrating a clear risk assessment.

Also read: How to create a temperature mapping protocol in pharma

3. Define sensor placement to cover high-risk zones

A risk-based approach ensuresthe strategic placement of data loggers rather than using a fixed grid method alone. To minimize blind spots, sensors should be placed in areas prone to temperature fluctuations, including, but not necessarily limited to:

• Near doors and entry points, where airflow can cause temporary temperature or continuous instability
• Close to HVAC systems, where blowout air may impact storage conditions
• At known hot and cold spots, identified during previous mappings or pilot studies
• In operational risk zones, such as areas with frequent product movement

Best practice: Instead of using excessive data loggers across an entire facility, place fewer, well-positioned sensors in high-risk areas to ensure efficient and compliant monitoring.

4. Justify testing decisions to auditors

Regulatory audits focus on how well you justify your temperature mapping strategies. A strong risk-based mapping approach includes:

• Documented rationale for mapping frequency, sensor placement, and test methodologies.
• Clear links between risk assessment findings and mapping protocol decisions.

Best practice: Ensure all decisions are supported by evidence and real-world data to demonstrate a well-structured, risk-based compliance approach.

5. Establish a clear re-mapping policy based on risk indicators

Traditional GxP temperature mapping requires periodic full-scale re-mapping. This method can be costly, time-consuming, and inefficient.

Rather than relying on fixed re-qualification timelines (e.g., every three years), risk-based temperature mapping triggers re-mapping based on key risk indicators.

Tip! Eliminate re-mapping with continuous mapping

A risk-based approach can incorporate continuous mapping or validation, ensuring compliance without the need for re-mappings. This is done by:

• Implementing extended monitoring of critical zones continuously rather than re-mapping an entire facility.
• Re-assessing risks dynamically when operational changes occur (e.g., warehouse layout changes, new equipment installations).
• Using data trends and alarm patterns to trigger re-mapping only if significant changes occur.

Learn more here: “Continuous temperautre mapping: A framework to eliminate re-mapping”.

Some indicators that a re-mapping can be required:

• Significant operational changes, e.g., new storage equipment and changes in warehouse layout.
• Environmental shifts, like modifications to HVAC systems and insulation changes.
• Temperature trend deviations, e.g., increasing fluctuations in monitored zones.
• Frequent alarms or non-conformities, e.g., consistent alerts in previously stable areas.

Best practice: Set up a review interval (for instance, annually) to assess whether remapping is necessary rather than following a rigid requalification schedule.

The main principles of risk-based temperature mapping

In summary, these are the key principles of a risk-based approach to mapping:

Want to implement risk-based temperature mapping in your GxP facility?

Contact us to learn how to develop a customized, risk-based validation strategy that meets regulatory expectations while optimizing your temperature compliance program.