A recall is a search problem: from batch number to consignee before the day is over

The email from the manufacturer arrives at twenty to four on a Friday. One batch of a prescription product is to be quarantined and recalled. At the distributor, the person responsible for quality has one question to answer before anything else can happen: where is it?

Some of it is on a shelf. Some was picked this morning for Monday’s run. The rest went to eleven customers over the past six weeks. She pulls sales lines from the ERP, locations from the warehouse spreadsheet and signed delivery notes from a binder. By Saturday lunchtime she has a list she is fairly sure of.

Nobody did anything wrong. Every record existed. They were in three places, and only one of them carried the batch number.

What the guidelines actually ask

The EU guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) are specific on this, and short.

• Section 4.2. Records must include the date, the product name, the quantity, the name and address of the supplier, customer or consignee, and the batch number at least for products bearing the safety features. Documents are kept for the period national law sets, and at least five years.
• Section 5.8. Every supply is accompanied by a document that states, among other things, the batch number, the quantity supplied and the name and delivery address of the consignee.
• Section 6.5. Recall operations should be capable of being initiated promptly and at any time. The distribution records should be readily accessible to the person responsible for the recall. The effectiveness of the arrangements should be evaluated regularly, at least annually.

“Promptly and at any time” includes a Friday at twenty to four. Medical devices and other regulated goods have their own rules, but the practical demand is the same: start from a batch and arrive at every place it went.

Three questions, three different records

• Where is it in our building? Stock by batch and by location, including what is reserved, what is picked and waiting, and what is already in quarantine.
• Who received it? Deliveries by batch: consignee, address, date and quantity, as delivered. The order is not the answer. The order said ten, eight were delivered, and the picker took them from a different batch than the one the system suggested.
• Can we show what we did? Who blocked the batch and when, who was told, what came back. Then the reconciliation: quantity received equals quantity in stock, plus delivered, plus returned, plus destroyed.

An inspector goes straight to the reconciliation, because it does not balance when the first two records are approximate.

Where the trail breaks

• The batch is recorded at goods-in and not at the pick. The stock record knows which batches are in the building. Nothing knows which one left.
• The delivery note is printed from the order. It was produced before picking and states what was meant to happen.
• Returns go back on the shelf without a batch. The goods are in the building again, but the record no longer says which batch they belong to.
• The transport leg is somebody else’s paper. The goods were handed to a carrier, and the signed proof of delivery is in a cab, a scanner queue or a different company’s system.
• A correction has no author. A stock adjustment of minus six with no reason and no name is a gap in the reconciliation that nobody can close afterwards.

The record has to be hard to change

A record that anyone can tidy up after the event proves little. That is the trouble with the spreadsheet and the binder, however carefully they are kept. What gives a distribution record its weight is that each entry carries who made it and when, that corrections are added as new entries instead of overwriting old ones, and that a document cannot be altered once it has been issued.

Where the record is kept matters as well. A distribution record lists which hospitals, clinics and pharmacies received which products on which days. Customers in public healthcare ask where that data is hosted and under whose jurisdiction, and they expect a precise answer.

What a system does not give you

• It is not your quality system. The procedure, the responsible person, the decision to recall and the contact with the authority stay with you.
• It does not qualify itself. Showing that a computerised system is fit for its intended use is your work, whichever system you choose.
• It does not scan for you. A batch that is not captured at the pick is not in the record, however good the record is.

Run the drill

Pick a batch that shipped four to six weeks ago and start a clock. Produce the stock by location, the list of consignees with quantities and dates, the signed proofs of delivery and the reconciliation. Stop the clock.

The guidelines ask you to evaluate your recall arrangements at least once a year anyway. The elapsed time is the number worth tracking from one year to the next. If it comes in under an hour, the records are doing the work. If it takes a day, people are doing it.

Where navichain stands

navichain holds stock at lot level, per article and per warehouse, with every receipt, pick and correction on an audit trail and a field-level audit trail on the records that matter. Goods you take in get a sealed, barcoded goods receipt note. Goods you hold in custody for a customer are tracked separately from your own stock.

The delivery is in the same system as the stock. Each drop produces its own digital consignment note naming its consignee, and the proof of delivery is sealed, hashed and timestamped on the driver’s phone. “Who received this batch?” is answered from what was delivered, with the signature attached, and the transport leg is no longer a separate search. Incidents and corrective actions are tracked as tasks with an owner. Vehicle temperature-control classes and drivers’ GDP certificates sit among the 26 regulations the platform enforces at the point of work.

Each customer’s data is held in its own isolated database within the EU, with role-based permissions and two-factor authentication for administrators, and you can export it at any time.

This is in daily use. Nimes Transport AB is a key reference customer that has used navichain for many years to meet the requirements of GDP and the demands of its customers and its market. That use has driven navichain’s development, and it has made both Nimes and navichain better. The platform page sets out what sits inside.