FAQ

How often does a 3PL need to be re-qualified and audited?

Question:
Hi PharmaGroup,
We are a pharmaceutical wholesaler in Denmark using a 3PL. We qualified the 3PL three years ago. How often do we need to re-qualify and conduct an audit of the 3PL?

Answer:
Dear questioner,

Under GDP, a contract acceptor such as a 3PL must be audited before the outsourced activities begin and regularly thereafter. The frequency is not meant to be arbitrary but based on a documented risk assessment.

That said, for companies operating in Denmark, the expectation from the Danish Medicines Agency is clear: contract acceptors should be audited at least every three years. For new contract acceptors, the first audit after go-live is expected within the first year.

So in your case, if the 3PL was qualified and audited three years ago, it would generally be time to perform a new audit now.

Re-qualification should also not be seen only as a fixed calendar exercise. It should be a documented reassessment of whether the 3PL remains suitable for the outsourced GDP activities. This should take into account not only the audit itself, but also the 3PL’s performance over time, including deviations, complaints, temperature excursions, CAPAs, relevant changes, and whether the quality agreement and responsibilities remain adequate and up to date.

In other words, the audit interval is risk-based, but in Denmark the regulatory expectation is at least every three years, supported by continuous ongoing oversight in between audits.

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Have a question that is not covered here?
For GDP-related questions, send it to gdp@pharma-group.dk in Danish or English and get a direct answer from one of our experts.

For questions related to PharmaGroup’s other areas of expertise, please contact info@pharma-group.dk

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