Shipping Temperature‑Sensitive Materials: Best Practices for CRT & Cold Chain

Shipping temperature‑sensitive materials is one of the few operational areas where small execution details (pack‑out choices, where a logger sits, who reviews the graph) can determine whether you accept a lot, quarantine it, or start a deviation. The practical goal is not perfection; it is repeatability: the same lane, pack‑out, and review logic should produce predictable outcomes.

International GDP and TTSPP guidance consistently emphasize risk‑based route controls, calibrated monitoring, documentation, and the ability to demonstrate that excursions do not adversely affect quality. 

Educational use only. This content does not replace your internal procedures, quality system, contracts, product labeling, or regulatory commitments.

1) Standardize two or three pack‑outs for your most common lanes

Most organizations accumulate too many packaging configurations (“just in case”). That creates avoidable failure modes: inconsistent conditioning, inconsistent assembly, inconsistent payload loading, and inconsistent performance.

A better model: 2–3 qualified pack‑outs that cover the majority of shipments by volume and risk.

What “standardize pack‑outs” means in practice

A pack‑out is not just “a shipper.” It is a controlled configuration:

• shipper type (passive insulated vs active),

• insulation and closure method,

• coolant type (gel/PCM/dry ice) and conditioning regime,

• coolant quantity and placement,

• payload size/thermal mass range,

• dunnage and internal layout,

• seal/tamper evidence,

• and the expected lane duration (including holds).

WHO TTSPP guidance is explicit that insulated passive containers should be qualified with full details of the assembly, conditioning regime, minimum/maximum shipping volume/weight/thermal mass, and correct placement of temperature monitors—while taking account of route and anticipated ambient temperature profile over the transport duration. (World Health Organization)

A simple lane → pack‑out selection logic

Start with the lanes you actually run (top 5–10 by volume or criticality), then group them by:

• duration (door‑to‑door plus realistic holds),

• seasonality (summer/winter profiles),

• mode (ground, air),

• handoffs (cross‑dock, customs),

• storage condition (CRT vs refrigerated vs frozen per label/spec).

PIC/S GDP also highlights route risk assessment to determine where temperature controls are required, and expects temperature monitoring equipment to be maintained and calibrated. 

Example of a 3‑pack‑out “portfolio” (illustrative)

Use your own labeled ranges and stability profile; the point is limiting variability:

• Pack‑out A (CRT, short duration): passive shipper qualified for typical domestic lane durations

• Pack‑out B (CRT, extended / high‑risk season): passive shipper with longer qualified duration (or active, if warranted)

• Pack‑out C (Cold chain): 2–8°C (or other labeled range) shipper qualified for international air + clearance holds

WHO also includes expectations to select shipping containers that protect product against the anticipated ambient temperature range and to pack containers to the exact specified configuration to maintain the required temperature range (including protection for freeze‑sensitive products when frozen packs are used). (World Health Organization)

Copy/paste: Pack‑out standard (one page per pack‑out)

Pack‑out ID:
Intended temperature range: (per label/spec)
Lane category covered: (e.g., domestic ground ≤48h; intl air ≤120h)
Seasonality: Summer / Winter / All seasons (as qualified)
Shipper type: Passive / Active
Coolant type & conditioning:
Payload limits: min/max volume, weight, thermal mass
Assembly steps: (numbered)
Pack diagram reference: (internal)
Seal/tamper method:
Logger requirement: (Y/N; placement location(s))
Release check before dispatch: (e.g., coolant conditioned, correct config, documentation complete)
Deviations: what to do if assembly differs from spec

2) Set logger placement rules and train teams on reading the data

Temperature data only helps when it is comparable across shipments. If logger placement changes each time, your dataset becomes noisy and excursion decisions become subjective.

Placement rules should be based on “worst‑case,” not convenience

WHO TTSPP guidance explicitly calls for monitoring sensors to be located to monitor worst‑case temperatures and positioned to monitor worst‑case positions (e.g., in temperature‑controlled vehicles and storage zones). (World Health Organization)

EU GDP guidance also expects temperature monitoring equipment to be located according to the results of temperature mapping, with adequate records generated and maintained, and equipment calibrated appropriately with traceability.

Practical logger placement rules (common, defensible)

For small passive shippers (parcel)

• Place the primary logger in the payload space that best represents product exposure.

• Prevent false lows/highs:

  • do not place logger in direct contact with gel packs/PCM/dry ice,

  • avoid placing against the shipper wall without justification,

  • use a consistent placement (e.g., “center of payload, mid‑height”) unless your qualification indicates a different worst‑case.

For pallets or larger shippers

• Use multiple loggers if the load is large or risk is high:

  • top layer + bottom layer,

  • center + a “most exposed” corner,

  • any known hot/cold zones from mapping/qualification.

For active containers

• Place at least one independent logger in the payload space (separate from the container’s own control sensor), consistent with your SOPs and qualification approach.

Sampling frequency and calibration

WHO TTSPP guidance includes expectations for calibrated monitoring devices against a certified, traceable reference standard (often at least annually unless justified), and notes that recording frequency should take account of logger capacity and expected transport period. (World Health Organization)

Train teams to interpret temperature traces consistently

Your training objective is not “how to download a file.” It is “how to make the same call on the same trace.”

Train on:

• identifying the valid monitoring window (when shipment responsibility begins/ends),

• recognizing common artifacts (door openings, sensor startup, thermal lag),

• confirming data integrity (clock/time zone alignment, missing segments),

• summarizing exposure in a consistent way (time out of range; min/max; repeated excursions).

Copy/paste: Logger placement & data review SOP snippet (minimum viable)

When a logger is required: (by material category, lane, or temperature range)
Logger configuration: device type, calibration status, sampling interval, start/stop rules
Placement (by pack‑out ID):

• Pack‑out A: location __

• Pack‑out B: location __

• Pack‑out C: location __

Receiving review steps (standard):

1. Confirm shipment ID, lot, and logger ID match documentation

2. Confirm data integrity (continuous record; correct time window)

3. Compare to allowed range and excursion rules

4. Document conclusion and disposition pathway (accept/quarantine/escalate)

5. File trace and summary in the shipment record

3) Define an excursion decision tree with clear ownership

The fastest way to create delays is to treat every excursion as a brand‑new debate. Define decision logic once, then apply it consistently.

WHO TTSPP guidance states that TTSPPs should be transported so that excursions above or below the manufacturer’s labeled storage temperature range do not adversely affect product quality, supported by product stability data. (World Health Organization)

For products stored below room temperature, ICH Q1E also calls for a discussion addressing the effect of short‑term excursions outside the label storage condition (e.g., during shipping or handling), and notes this can be supported by further testing where appropriate. (European Medicines Agency (EMA))

Clear ownership (recommended operating model)

• Supply Chain / Logistics: ensures logger data is retrieved, lane details captured, pack‑out confirmed

• Quality (QA/QCU): owns final disposition decision and excursion documentation

• Technical / CMC / Stability (as needed): provides product‑specific stability rationale and risk assessment support

• Supplier/3PL: provides lane event details, dwell times, corrective actions

Copy/paste: Excursion decision tree (text format)

Trigger: Temperature data indicates potential excursion OR data gap.

1. Data integrity check

   • Logger ID matches shipment? Y/N

   • Data complete (no gaps) and time window correct? Y/N

   • If N → classify as Data Issue → quarantine + investigation path.

2. Confirm applicable limits

   • Use labeled/storage specification + internal allowable excursion policy for this material/lane.

3. Classify event

   • No excursion: within limits → accept (document review).

   • Minor excursion: brief, small magnitude, within pre‑approved criteria → accept with documented rationale.

   • Moderate excursion: exceeds minor criteria → quarantine + QA review; consult stability/technical rationale.

   • Major excursion: extreme temp, long duration, freeze event for freeze‑sensitive products, or repeated excursions → quarantine; likely reject or require defined testing/risk assessment.

4. Disposition decision (QA owner)

   • Accept / Accept with justification / Quarantine pending assessment / Reject

5. Documentation package

   • Trace file + summary (min/max, duration, segments)

   • Lane narrative (what happened, where, for how long)

   • Decision rationale (link to stability/excursion policy)

   • CAPA/escalation if recurring

Key design principle: If the same magnitude/duration happens twice, the decision should not depend on who is on shift.

4) Record decisions, owners, and due dates

This prevents “tribal knowledge” shipping practices.

Copy/paste: Cold chain governance decision log

5) File supporting documents with the final record

Your “final record” should be sufficient to answer, later: What pack‑out was used, what did the logger show, and why did QA accept it?

GDP guidance emphasizes maintaining adequate records for mapped storage/monitoring and calibrated equipment; apply the same discipline to shipping lanes and shipments.

Copy/paste: Shipment record filing checklist (practical)

• Shipment ID, lane, mode, dates/times (dispatch to receipt)

• Pack‑out ID and confirmation it matched the standard configuration

• Logger ID(s), calibration status reference, sampling interval

• Raw temperature trace(s) + summary

• Excursion assessment form (even if “no excursion”)

• QA disposition and approvals

• Deviation/investigation and CAPA links (if applicable)

• Carrier/3PL event report (if there was a delay or handling excursion)

6) Schedule a follow‑up review to capture lessons learned

Shipping systems drift. Lanes change, carriers change, seasons change, and “temporary” workarounds become permanent. A scheduled review turns shipping into a managed process.

WHO TTSPP guidance ties compliance to demonstrating that the product stayed within the defined transport temperature profile and that documentation can be produced for regulators and stakeholders. Periodic review is how you keep that demonstration reliable. (World Health Organization)

What to review (keep it short and actionable)

• Excursion rate by lane and by pack‑out

• % shipments with missing/invalid logger data

• Average disposition cycle time (receipt → QA release)

• Top 3 root causes (conditioning errors, dwell times, incorrect pack‑out selection, handling)

• Whether pack‑outs still cover actual durations (including customs/last‑mile)

Copy/paste: 30–45 minute review agenda

1. KPI summary (excursions, data integrity failures, release cycle time)

2. Review worst 3 shipments (what failed and why)

3. Pack‑out performance: any lanes exceeding qualified duration?

4. Training gaps and corrective actions

5. Decisions to update pack‑outs, logger rules, or excursion criteria (owner + due date)

Closing point

If you standardize pack‑outs, standardize logger placement, and standardize excursion disposition logic—with named owners—you convert cold chain management from “heroics” into a controlled, auditable process consistent with GDP/TTSPP expectations for risk‑based route controls and documented temperature compliance.

Checklist

• Standardize two or three pack‑outs for your most common lanes.
• Set logger placement rules and train teams on reading the data.
• Define an excursion decision tree with clear ownership.
• Record decisions, owners, and due dates.
• File supporting documents with the final record.
• Schedule a follow‑up review to capture lessons learned.

Notes:

This checklist is for educational use only and does not replace your internal procedures.