Explain the Good Distribution Practice requirements that apply to a medicines storage and distribution site.
Warehousing & Procurement
Temperature Mapping Studies and Good Distribution Practice in Medicines Warehouses
Run temperature mapping studies and manage Good Distribution Practice compliance for medicines warehouses, covering storage qualification, ongoing monitoring, excursion investigation and transport assurance.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A cold room that averages an acceptable temperature can still hold a corner near the door that drifts out of range for hours at a time, and under Good Distribution Practice that hidden hot spot is exactly what a temperature mapping study exists to find before it reaches a patient's medicine. This course works through the GDP framework for medicines warehousing, from the Responsible Person's duties and quality system requirements to translating a product's labelled storage condition into a defined, qualified warehouse zone. Delegates design a mapping protocol, place calibrated data loggers at worst-case locations across summer and winter campaigns, and calculate mean kinetic temperature to turn raw logger data into a qualification report. The course continues into ongoing monitoring, calibration and alarm design informed by the mapping study, structured investigation of temperature excursions, and extending the same qualification discipline into transport, packaging and distribution subcontractors.
Expected Learning Outcomes
Translate a product's labelled storage condition into a defined warehouse zone and equipment specification.
Design a temperature mapping protocol and place calibrated data loggers at worst-case locations across seasons.
Calculate mean kinetic temperature from mapping data and convert hot and cold spots into a qualified layout.
Set ongoing monitoring, calibration and alarm arrangements informed directly by the mapping study's findings.
Investigate a temperature excursion and decide on quarantine, release or rejection of the affected stock.
Extend temperature qualification into transport and assess a distribution subcontractor's monitoring evidence.
Who Should Attend
Warehouse and quality managers responsible for Good Distribution Practice compliance in a medicines site.
Responsible Persons and deputies accountable for a wholesale dealer's licence obligations.
Validation and qualification specialists planning or reviewing a temperature mapping study.
Pharmaceutical distribution and third-party logistics staff handling temperature-sensitive medicines.
Quality assurance auditors preparing a site for a GDP inspection or customer audit.
Transport and packaging engineers qualifying vehicles and packaging for medicines distribution.
Course Modules
Select any module to see its sessions and points.
01GDP Framework for Medicines Warehousing
2 sessions · 8 points
Session 1Good Distribution Practice Requirements
- Define the scope of Good Distribution Practice guidelines as they apply to storage and distribution of medicinal products.
- Describe the Responsible Person's role and duties within a GDP-licensed warehouse operation.
- Identify the quality management system elements a GDP site needs, including SOPs, deviation handling and self-inspection.
- Interface warehouse GDP controls with the obligations attached to a wholesale dealer's licence.
Session 2Temperature-Controlled Storage Requirements
- Define storage condition categories such as cold chain, controlled room temperature and frozen storage.
- Translate a product's labelled storage condition into a specific warehouse zone specification.
- Assess racking, HVAC and refrigeration design needed to hold a declared temperature range reliably.
- Plan contingency arrangements for a power failure or refrigeration breakdown affecting stored medicines.
02Designing and Running a Temperature Mapping Study
2 sessions · 8 points
Session 1Mapping Protocol and Data Logger Placement
- Write a temperature mapping protocol that defines objectives, acceptance criteria and study duration before installation.
- Place calibrated data loggers at worst-case locations such as near doors, heaters, corners and varying heights.
- Run summer and winter mapping campaigns to capture seasonal temperature extremes across the storage area.
- Capture a door-open or high-throughput event within the mapping period to test worst-case resilience.
Session 2Analysing Mapping Data and Qualifying the Space
- Calculate mean kinetic temperature from logged data to assess cumulative thermal exposure over the study period.
- Identify hot and cold spots from mapping data and translate them into exclusion zones or racking changes.
- Compile a qualification report that links installation, operational and performance qualification evidence.
- Set the routine monitoring sensor layout using the worst-case locations identified by the mapping study.
03Ongoing Monitoring, Excursions and Deviations
2 sessions · 8 points
Session 1Continuous Monitoring and Calibration
- Select and site permanent monitoring sensors using the worst-case locations found during mapping.
- Set a calibration and verification schedule for data loggers and monitoring sensors in ongoing use.
- Configure alarm thresholds and escalation routes that trigger when a reading moves out of range.
- Maintain monitoring records in a form and retention period that supports a GDP inspection.
Session 2Managing Temperature Excursions
- Define an excursion investigation process that assesses product impact using stability or mean kinetic temperature data.
- Decide on quarantine, release or rejection of stock affected by a recorded temperature excursion.
- Record corrective and preventive actions arising from each temperature deviation investigation.
- Report significant excursions to the Responsible Person and, where required, to the relevant regulator.
04Extending GDP Assurance Across the Supply Chain
2 sessions · 8 points
Session 1Transport and Distribution Qualification
- Extend temperature qualification from the warehouse into vehicles, totes and last-mile transport legs.
- Assess packaging and passive cooling solutions against a defined transport duration and ambient profile.
- Audit a transport subcontractor's temperature control, monitoring and record-keeping evidence.
- Set re-qualification triggers for a new route, vehicle type or packaging change affecting the cold chain.
Session 2Supply Chain Security and Continuous Improvement
- Apply supply chain security checks that reduce the risk of falsified or diverted medicines entering stock.
- Schedule self-inspections and management review of the site's GDP quality system.
- Use excursion and deviation trends to prioritise the next facility, equipment or process investment.
- Prepare mapping and monitoring evidence ready for a regulatory inspection or customer GDP audit.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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