Manufacturing
Pharmaceutical and medical devices
Batch traceability, storage conditions and documentation that cannot be improvised.
In pharmaceuticals and medical devices everything explained in other sectors applies the same, only with no margin. Batch traceability is not good practice: it is the condition for recalling a product without recalling a year's production.
What gets cross-referenced
| What | With what | For what |
|---|---|---|
| Each manufactured batch | The raw material batches that went in | Scoping a recall |
| Each shipment | Its transport and temperature conditions | Proving they held |
| Each supplier | Their qualification on the supply date | Answering an inspection |
| Each person | Their current training on that date | Justifying who did what |
Important
The question is always in the past tense and always specific: which raw material went into batch X, under what conditions did it travel, and who was qualified that day. A system reporting only today's status answers none of the three.
What must be provable with no margin
Watch out
Certifying records periodically matters more here than in any other sector: an editable temperature or process record does not count as evidence before an authority, however well kept.
Frameworks cited
Good manufacturing and distribution practices, traceability and serialisation requirements, and — for medical devices — the specific regulation with its technical documentation and post-market surveillance. The exact scope and required validations are confirmed by your technical lead or regulatory adviser; this help centre replaces neither.
Worth knowing
If you work in this sector you probably already have a validated system. What is explained here fits as a documentary layer over suppliers and third parties, not as a replacement for your quality system.
›Does it replace my quality system?
No, and it should not try. It covers the documentary relationship with third parties.
›Does it serve for an inspection?
Dated records and per-supplier history are what is asked for.
›What about validation?
Check with your technical lead before using it for anything critical.
A real case
The situation
A distributor must scope an alert on a batch from fourteen months ago.
What you do
- Checks which source batches went in and under what conditions they travelled
What you get
Narrows it to two shipments instead of a whole quarter of dispatches.
The situation
A process change is applied before being documented.
What you do
- Records the change before applying it
What you get
The file describes what is done.
The situation
A batch needs documents from three departments.
What you do
- Gathers them in the batch's file
What you get
Release does not wait on searching.
The situation
A review asks about a batch from two years ago.
What you do
- Keeps the file with its date
What you get
You answer from the archive.
The situation
Supplier documentation expires with material in stock.
What you do
- Records expiries per supplier
What you get
The warning arrives before producing with it.
The situation
A deviation is resolved and the basis is not recorded.
What you do
- Records the decision and who took it
What you get
The deviation is explicable afterwards.
This article answers
- pharmaceutical batch traceability
- pharma supplier documentation
- good distribution practice documentation
- medical device chain of custody