---
id: KB-LG-014
url: https://app.codecontract.io/help/logistics/pharmaceutical-distribution-and-sensitive-goods
idioma: en
categoria: sector-logistica
subcategoria: farmaceutica
audiencia: usuario
nivel: avanzado
actualizado: 2026-08-13
tambienEn: [es]
relacionados: [KB-CS-031, KB-LG-004]
citadoPor: [KB-IU-002]
---

# Pharmaceutical distribution and sensitive goods

_Here documentation does not accompany the shipment: it is part of the product, and without it the product is worthless._

**Responde a:** pharmaceutical distribution documentary requirements · temperature-sensitive product transport · pharmaceutical batch traceability · who may handle pharmaceutical product

In most sectors, a documentary failure is an administrative problem solved by asking for the paper again. In pharmaceutical and medical goods distribution it is not: if you cannot evidence the conditions a batch was kept in, that batch cannot be sold, however perfect it is.

## The four things to evidence for every batch

| What | Why | Where it is lost |
| --- | --- | --- |
| Where it came from and where it went | It is the basis of any recall | When dispatch is recorded by customer rather than by batch |
| The conditions in transit and storage | It defines whether the product is still fit | Records exist and are not linked to the batch |
| Who handled it and with what qualification | Some functions cannot be done by anyone | It is checked at hiring and not afterwards |
| What was done about a deviation | The reaction is judged as much as the event | It is resolved by phone and leaves nothing |

> [!IMPORTANT]
> The second row decides the value of the goods and is the worst linked. Holding a lorry's temperature record is worth nothing if you cannot say **which batches were inside**: the record proves the vehicle stayed in range, not that this particular product did. That link is the whole job, and it is what goes wrong when recording is by vehicle rather than by shipment.

## The deviation, where everything is decided

1. **Recorded at the moment, with the real time** — And the affected product segregated before anything is decided.
2. **Decided against criteria written beforehand** — Improvising criteria during the deviation is what cannot be defended afterwards.
3. **Decided by whoever holds that function** — Not by whoever happens to be in the warehouse at that hour.
4. **And the decision recorded, not just the reading** — What was released, what was blocked and why, with a name.

> [!WARNING]
> The nuance that separates this sector from the rest: **documentation does not follow the product, it travels with it**. Product arriving without complete documentation is not product awaiting paperwork — it is product that cannot be released until resolved, and meanwhile it occupies space, expires and costs. Which is why here the record is taken at the door, not at the end of the day.

## What an inspection asks for

**En corto**

- The full history of a batch of their choosing, intake to dispatch.
- Conditions on each leg, linked to that batch.
- The period's deviations and what was decided in each.
- And the qualification of whoever was involved, valid on those days.

> [!NOTE]
> Specific distribution requirements, required qualifications and which records must be kept depend on the product type and the country, and they get updated. **Confirm with your technical manager or the competent authority**; this describes where the documentary chain breaks in practice.

**Is the carrier's record enough?**

As data yes; you must be able to link it to your batches and keep it yourselves.

**What if the customer detects the deviation on receipt?**

Treat it the same: record, segregate and decide against criteria, even though the product has left your hands.

**How long must it be kept?**

Beyond the product's life, with margin: it is among the most requested.

## Ejemplos

**A distributor keeps temperature records per vehicle rather than per shipment.**

- Links each record to the batches that were inside
- Writes the decision criteria before the next deviation

→ In an inspection it can evidence the conditions of that specific batch, not just the lorry's.

**The temperature log is filed loose.**

- Attaches it to the shipment on receipt

→ The log lives with the shipment it documents.

**A client asks for a specific shipment's traceability.**

- Checks that shipment's file

→ You answer per shipment.

**Driver documentation expires without warning.**

- Records expiries per person

→ The warning arrives before the job.

**The range is breached and it is accepted with no record.**

- Records the incident on receipt

→ The acceptance is explained.

**A review asks about shipments from two years ago.**

- Keeps the files with their dates

→ You answer from the archive.