How to launch facilities before the second seasonal mapping
You do not need to wait 6-12 months for a second seasonal mapping to begin operations. Strategy B allows you to operationalize GDP facilities after the first mapping by deploying increased monitoring coverage during the transition period, giving you compliant revenue-generating operations months earlier than traditional approaches.
Here is how to accelerate facility launches without compromising compliance.
Note!
This article is based on insights from "Mastering Temperature Mapping" by Jakob Konradsen, Chief Quality Officer at Eupry. For the complete methodology behind risk-based facility qualification, sign up to get notified when the book launches.
Do I have to wait for both seasonal mappings before using my facility?
No – if you implement appropriate risk controls.
Traditional seasonal mapping (Strategy A below) requires completing both summer and winter studies before taking a facility into full operation. This means 6-12 months of idle facility time, lost revenue opportunities, and delayed contract fulfillment.
Strategy B offers a compliant alternative: conduct your initial mapping, implement increased monitoring coverage, and begin operations immediately while waiting for the second seasonal study. This approach is explicitly supported by EMA GDP guidelines and WHO TRS 961, which allow risk-based commissioning strategies.
The key difference is that you are not operating blind during the transition period. You are operating with enhanced monitoring that provides real-time visibility into seasonal performance changes.
Why seasonal mappings are required in the first place
Before discussing how to accelerate the process, it is important to understand why two seasonal studies exist.
Temperature mapping is a point-in-time assessment. External conditions (outside air temperature, sun exposure, building heat load) can significantly impact how facilities perform. A warehouse that maintains 2-8°C perfectly in January may struggle to stay below 8°C during July afternoon heat.
Most GDP and GMP guidelines mandate seasonal mappings when external conditions could affect thermal performance. The EMA's "Guidelines on Good Distribution Practice" (2013) states:
"The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment."
For facilities in temperature-controlled buildings with stable year-round conditions, a single mapping may suffice. For facilities with external exposure or in unconditioned spaces, seasonal validation is typically required.
How Strategy A and Strategy B compare
Jakob Konradsen explains the two approaches in Mastering Temperature Mapping:
Strategy A: Sequential seasonal mappings
"Strategy A involves performing two seasonal mappings in their respective seasons one after another, while keeping the facility or equipment unused for critical processes in between. In this case, the first mapping is performed fully, a waiting period until the next season is taking place and then performing the last mapping."
Timeline: 12-18 months from start to full operation
Benefits:
- Full performance assurance before any operations begin
- Lower risk of unexpected seasonal impact
- Simpler monitoring requirements during qualification
Drawbacks:
- Extended commissioning timelines delay revenue
- Facility sits idle for 6-12 months
- Capital investment generates no return during waiting period
- Competitive disadvantage in time-sensitive markets
Strategy B: Monitored transition period
"Strategy B involves conducting the initial mapping exercise, after which an increased amount of dataloggers are placed in measurement positions and then conducting the last seasonal mapping. In the period between the first and second mapping, the facility can be taken into use."
Timeline: 3-6 months from start to full operation (depending on season)
Benefits:
- Begin revenue-generating operations immediately after first mapping
- Competitive advantage in pharmaceutical logistics contracts
- Capital starts generating ROI during transition period
- Maintains compliance through enhanced monitoring
Drawbacks:
- Requires additional monitoring equipment during transition
- Increased vigilance needed to detect seasonal changes
- Potential need to relocate products if unexpected issues arise
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How to implement Strategy B compliantly
The compliance foundation for Strategy B is simple: you are monitoring at mapping-level coverage during the transition period. This provides equivalent visibility to conducting a continuous study.
Here is how to structure it:
Step 1: Complete your initial mapping
Conduct a full temperature mapping study (summer or winter, depending on current season) following standard protocols:
- Empty and loaded conditions
- Stability testing (7+ days for warehouses)
- Door opening simulations
- Performance qualification tests
- Full documentation and reporting
This establishes your baseline performance and identifies hot and cold spots for the current season.
Step 2: Deploy increased monitoring coverage
Instead of reducing to 2-4 monitoring sensors in hot/cold spots (standard practice), maintain mapping-level sensor coverage:
- Keep sensors at all grid positions used during mapping
- Typical coverage: 20-50+ sensors depending on facility size
- Maintain placement rationale from mapping protocol (corners, risk zones, HVAC proximity, door areas)
Jakob notes: "The purpose of placing additional dataloggers, sometimes even the same amount as would be placed during a mapping exercise, is that performance can be closely monitored during operation, as there is sufficient evidence that if there are any changes from seasonal variations, that these are monitored during operation."
This is not "extra" monitoring – it is temporary enhanced monitoring that serves a specific validation purpose.
Step 3: Document your risk assessment
Your validation documentation must include:
Risk statement: "Based on initial [season] mapping results showing stable performance within acceptable ranges, and implementation of enhanced monitoring coverage during transition period, the facility is approved for operational use pending completion of second seasonal mapping."
Monitoring plan:
- Sensor locations and rationale
- Alert thresholds (tighter than standard operations)
- Review frequency (daily during first month, weekly thereafter)
- Escalation procedures if trends indicate seasonal impact
Contingency plan:
- Product relocation procedures if zones exceed limits
- Timeline for implementing corrective actions
- Communication plan for affected customers
Step 4: Monitor actively during transition
This is not passive monitoring. During the transition period:
- Daily reviews: Check for trending changes as seasons shift
- Weekly analysis: Compare current performance to initial mapping baseline
- Alert response: Investigate any excursions within 24 hours
- Documentation: Log all reviews and findings
Automated monitoring solutions significantly reduce the manual burden here, providing real-time alerts and trend analysis.
Step 5: Complete second seasonal mapping
When the opposite season arrives, conduct your second mapping study using the same protocol as the initial study. This provides the final validation that performance remains acceptable year-round.
After the second mapping confirms compliance, you can reduce monitoring to standard hot/cold spot coverage.
Next steps: Implementing Strategy B for your facility
Ready to implement Strategy B? Assess your facility's seasonal variation, plan your mapping timeline, secure monitoring equipment for 3-6 months, and document your approach in your mapping protocol.
Need help? Contact Eupry's validation team to discuss your facility timeline and monitoring requirements.
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