Temperature control & last mile: 2–8 °C and 15–25 °C

Temperature mapping for warehouses and routes

Risk determines protocol, season, load, hot and cold spots, sensor positions, acceptance criteria and requalification.

• 15–25 °C and 2–8 °C GDP mapping
• Summer, winter and worst case
• Calibrated loggers and sensor positions
• DQ, IQ, OQ and PQ
• Requalification after change

Assess temperature excursions

Affected stock is quarantined and evaluated using product, time, route, packaging and stability evidence.

• Alarm and quarantine
• Data and product assessment
• Release or rejection decision
• Root cause and CAPA

Product profile, storage zones & data

The starting point is not a generic cold label but the approved product information and stability evidence that is reliable for the particular supply chain.

• Align product and PZN data with manufacturer and release information
• Map and qualify warehouse temperature zones
• Define data ownership, version control and review cadence
• Do not assign a generic corridor without documented evidence

Packaging matrix & route qualification

Packaging, transit time and route are assessed as one configuration, including season, handover point and realistic delay scenarios.

• Product-, pack- and route-specific packaging matrix
• Passive or active solution only within a qualified configuration
• Document climate-chamber, duration and stress scenarios
• Define fallback, blocking or replanning when conditions are not met

Carrier SLA & validated last mile

The last mile is not determined by shipping method alone. Medicine, patient group, delivery location, handover and carrier performance form one risk profile.

• Choose carriers by product, geography and delivery risk
• SLA for lead time, deviation notification and escalation
• Identity, personal or contact-light handover according to risk
• Use KPIs, proof of delivery and partner reviews for ongoing control

Monitoring, calibration & evidence

Measurement should be meaningful, not decorative. Sensors, indicators and data loggers are selected according to the risk assessment and controlled by quality processes.

• Measurement concept by product, route and pack configuration
• Maintenance, calibration and functional-check concept
• Traceable data retention, access rights and records
• Data-minimised communication with patients and recipients

Deviation, return & quality decision

A temperature deviation or returned parcel is a quality case: secure first, assess second, then let the responsible role make a traceable decision.

• Block or quarantine pending quality assessment
• Assess time, route, measurements, packaging and product requirements together
• Document release, rejection or further investigation
• Use MKT only where product-specific stability data and written decision logic support it

B2B, B2C & cross-border supply chains

Warehouse and wholesale processes and direct patient delivery need different controls, but can be managed through one shared quality picture.

• Qualified warehouse, transport and outsourcing interfaces
• Separate rules for B2B handovers and B2C patient supply
• Review destination market, mandatory information and reporting before go-live
• Connect quality agreements, training and CAPA

Turn quality findings into storage and transport actions

If the assessment calls for changes to goods flows or providers, plan storage and transport together. Define handovers, data, partners and deviation controls in an operational work package. Quality findings and Responsible Person responsibilities inform that scope.

Coordinate goods handovers, providers, temperature data and operational tasks. Plan pharmaceutical transport and warehousing →