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Questions to ask when choosing a storage partner

Under EU GDP, a company that outsources storage assesses whether its partner is competent for the job. Licences, temperature mapping, monitoring and alarms, deviation reporting, reports, recalls and an exit plan are the main topics to cover in that assessment.

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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.

Outsourcing storage does not outsource responsibility for the product’s quality. Chapter 7 of the EU GDP guidelines, on outsourced activities, describes the relationship clearly. The contract giver assesses the competence of the contract acceptor. A written contract sets out the duties of each party. And the contract acceptor does not pass any of the work to a third party without the contract giver’s approval.

The questions below are a starting list for that assessment. Most of the answers should be backed by a document.

The facility and its conditions

Start with the site itself:

  • Which licences and certificates do you hold, and can I see current copies?
  • When were the storage areas last temperature mapped? Asking to see the report is a normal request.
  • Is temperature monitored continuously? When an alarm goes off outside working hours, who is alerted and what do they do?
  • How often is the monitoring equipment calibrated?
  • What happens in a power cut, and which areas does the backup power supply?

Records and reports

  • If there is a deviation, how and how quickly will I be told?
  • Which reports will I receive, how often and in what format? Sample stock, temperature and deviation reports make this concrete.
  • How are batch numbers and expiry dates tracked, and does stock rotate by FEFO?
  • For products that need İTS or ÜTS notifications, who makes them and how?

When things go wrong

  • How does your recall procedure work? When was the last mock recall, and what did it find? Our article on recall readiness covers what a good answer includes.
  • Where are returns and quarantined goods kept, and how are they separated from other stock?
  • How are stored goods secured, and who is responsible for insuring them?

The relationship itself

  • Are audits and visits welcome, and do they need notice?
  • Which systems are used to exchange orders and stock reports?
  • If the contract ends, how are the stock, the records and the data handed over? An exit plan is easiest to agree while the relationship is starting.

Once the contract is signed, the relationship needs measuring. We cover that in How to measure warehouse performance, and the wider framework in What is GDP?

References

  • European Commission, EU GDP Guidelines (2013/C 343/01), chapter 7

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