Regulation & Compliance Basics 2 min read

Recall readiness

A recall can start at any moment, and the first question is always the same: where is this batch? EU GDP asks for distribution records to be readily available and for recall arrangements to be evaluated at least once a year. A mock recall shows the gaps before a real one does.

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This content is for information only. It is not a regulatory interpretation, an audit opinion or a storage instruction for your product. The approved label and the current guidance of the competent authority take precedence.

A recall can start at any moment, and the first question is always the same: where is this batch? A warehouse that can answer quickly and completely has solved the hardest part of a recall before it begins. That is why the preparation happens before any recall arrives.

What does GDP ask for?

Chapter 6 of the EU GDP guidelines sets a few clear expectations:

  • Recall operations can be started promptly and at any time.
  • Distribution records are readily available to the people responsible for the recall. They hold customers’ addresses and contact details for inside and outside working hours, batch numbers and quantities delivered, including exported products and samples.
  • Each recall is recorded as it happens, and its progress is written up in a final report.
  • The effectiveness of the recall arrangements is evaluated regularly, at least once a year.

What is the warehouse’s part?

The decision to recall comes from the product owner or the competent authority, and the product owner handles the formal notifications. The warehouse makes that decision workable on the ground. The steps usually run like this:

  1. The affected batches are found in stock and blocked at once: physically segregated, and blocked in the system so they cannot ship.
  2. Every dispatch of those batches is listed with the customer, the date and the quantity.
  3. The notifications the product owner sends to customers rely on that list.
  4. Returned goods are received into a separate area and never mix with saleable stock.
  5. Quantities delivered and quantities recovered are reconciled, and any gap is explained.
  6. A record is kept of every step.

All of this depends on batch traceability being right from the start. If the batch number was not captured at receipt or at dispatch, step two turns into guesswork.

What does a mock recall show?

The best way to measure readiness is a test run. A real batch is chosen and its dispatch list is produced as if it were being recalled, without moving any goods. The exercise shows two things: how long it takes to produce the list, and where the gaps are. A missing customer phone number, a sample shipment the system does not show or a record kept by hand comes to light before a real recall exposes it.

The result of the mock recall is recorded too. It can feed the regular evaluation of the recall arrangements.

In short

Recall readiness shows in the records. The date of the last mock recall and what it found say a great deal about a warehouse. The wider framework is covered in What is GDP?

References

  • European Commission, EU GDP Guidelines (2013/C 343/01), chapter 6
  • WHO Technical Report Series No. 1025, Annex 7: Good storage and distribution practices for medical products (2020)

Information only; not a regulatory interpretation or a storage instruction.