Logistics
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.
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.
Watch out
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
Worth knowing
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.
A real case
The situation
A distributor keeps temperature records per vehicle rather than per shipment.
What you do
- Links each record to the batches that were inside
- Writes the decision criteria before the next deviation
What you get
In an inspection it can evidence the conditions of that specific batch, not just the lorry's.
The situation
The temperature log is filed loose.
What you do
- Attaches it to the shipment on receipt
What you get
The log lives with the shipment it documents.
The situation
A client asks for a specific shipment's traceability.
What you do
- Checks that shipment's file
What you get
You answer per shipment.
The situation
Driver documentation expires without warning.
What you do
- Records expiries per person
What you get
The warning arrives before the job.
The situation
The range is breached and it is accepted with no record.
What you do
- Records the incident on receipt
What you get
The acceptance is explained.
The situation
A review asks about shipments from two years ago.
What you do
- Keeps the files with their dates
What you get
You answer from the archive.
This article answers
- pharmaceutical distribution documentary requirements
- temperature-sensitive product transport
- pharmaceutical batch traceability
- who may handle pharmaceutical product