SUPPLY CHAIN MANAGEMENT protection. The supplier needs to explain whether the longer journey remains within the report ' s supported conditions. A delivery estimate tells the laboratory when to expect a parcel; qualification addresses what the package can withstand.
Route profiling helps make that test realistic. The WHO describes gathering representative environmental information across routes and seasons to inform shipping arrangements. 4 For our Friday shipment, a profile that overlooks a prolonged depot stop may miss the part of the journey that caused concern.
The package report and the material ' s stability information answer different questions. One concerns the protection provided by a shipping system; the other concerns the material ' s response to exposure( Figure 1).
Read the graph in context
Back at the bench, the temperature trace still needs interpretation. Was the sensor beside the vials, beside a coolant pack or outside the insulated container? A reading of external air describes a different exposure from a reading at the payload. Even an accurate sensor can give an unhelpful answer if its location is misunderstood.
The WHO ' s transport monitoring guidance addresses device selection, installation, calibration evidence and handling the resulting data. 5 In practical terms, the lab needs enough context to associate the trace with this shipment and understand what its readings represent.
The temperature extremes are only part of the story. Duration and gaps in the trace also matter. A parcel that feels cool on arrival cannot reveal an earlier warm period, while a logger does not
References: 1: International Council for Harmonisation( ICH), Q1A( R2): Stability Testing of New Drug Substances and Products, 2003, Sections 1.1 – 1.3 and 2.1.4 – 2.1.7. https:// www. fda. gov / media / 71707 / download 2: S. Sahakijpijarn et al., Pharmaceutics, 2019, 11( 10), 498, Sections 2.12 and 3.5. DOI: 10.3390 / pharmaceutics11100498. https:// pmc. ncbi. nlm. nih. gov / articles / PMC6835953 / 3: World Health Organization( WHO), Qualification of Shipping Containers, Technical Supplement 13 to TRS 961, Annex 9, May 2015, Sections 2.1 – 2.5. https:// cdn. who. int / media /
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docs / default-source / medicines / norms-andstandards / guidelines / distribution / trs961- annex9-supp13. pdf 4: World Health Organization( WHO), Transport Route Profiling Qualification, Technical Supplement 14 to TRS 961, Annex 9, May 2015, Sections 1 – 2.3. https:// cdn. who. int / media / docs / default-source / medicines / norms-andstandards / guidelines / distribution / trs961- annex9-supp14. pdf 5: World Health Organization( WHO), Temperature and Humidity Monitoring Systems for Transport Operations, Technical Supplement 15 to TRS 961, Annex 9, May 2015, Sections
Preserve the record
Temperature history, shipment details & data gaps
Establish the exposure
Magnitude and duration; packing & monitoring context
Compare material-specific evidence
Material, presentation & tested conditions
Figure 2- Assessing a temperature departure
directly measure chemical degradation. These observations become useful when they can be compared with relevant stability information.
Decide whether to proceed
The final conversation is about whether the laboratory has enough information to use the material. Health Canada ' s drug-distribution guidance calls for documented excursion assessments and decisions supported by evidence. 6 Its approach provides a useful reference for the research laboratory ' s investigation( Figure 2).
For the hypothetical shipment, the supplier may produce applicable stability data and shipment evidence that together support proceeding. Alternatively, gaps in the record or limits in the stability data may leave suitability unresolved. A confident reassurance cannot close that gap.
Further testing could help, provided the method and acceptance criteria address the uncertainty. Otherwise,
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Document the decision
Decision-maker, evidence, uncertainty & next action
1.1 and 2.2. https:// cdn. who. int / media / docs / default-source / medicines / norms-andstandards / guidelines / distribution / trs961- annex9-supp15. pdf 6: Health Canada, Guidelines for Environmental Control of Drugs during Storage and Transportation( GUI-0069), August 2020, Sections 5.1( 7), 5.3( Temperature-Excursion Assessment) and 5.4( 4). https:// www. canada. ca / en / health-canada / services / drugs-healthproducts / compliance-enforcement / goodmanufacturing-practices / guidance-documents / guidelines-temperature-control-drug-productsstorage-transportation-0069. html postponing the run or obtaining replacement material may be the more defensible choice. The person responsible for the experiment should understand what remains unknown before the reagent is used.
The better time for that conversation is before dispatch. Buyers and suppliers should agree which material and container the stability information covers, which package configuration and journey duration are supported, and what shipment records will reach the laboratory. They should also agree who assesses an excursion, what information that person needs and how the decision reaches the researcher.
At 14.00 on Friday, the cost of losing the instrument slot is visible. The cost of an experiment whose starting material cannot be adequately assessed may appear later, when an unexpected result needs explaining. A useful shipping claim gives the laboratory enough substance to resolve that choice before the experiment begins. ●
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Emma Reed
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PUFFIN PEPTIDES support @ puffinpeptides. ca https:// puffinpeptides. ca
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