IMPs: How do GDP Guidelines apply?

Recommendation

13/14 December 2023

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How to conduct and pass GDP Audits and Inspections

The 2013 Guidelines on Good Distribution Practice (2013/C 343/01) apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines? The Guidelines focus on wholesale distribution of medicinal products. And IMPs are normally not distributed via wholesalers. However IMPs are not particularly excluded. The Guideline may therefore give some guidance on how to supply clinical trail material. Better guidance might be given by the Questions and Answers documents of the European Medicines Agency. In the part on supplementary requirements, Annex 13 a few Q&As are dealing with storage and transportation of IMPs.

When it comes to transport of IMPs from the manufacturer to the distributor or investigator sites, the sponsor is responsible for controlling the distribution chain and assuring "that IMPs are stored, transported, and handled in a suitable manner". The responsibility for storage and transportation lies with the manufacturer or an importer, when the IMP comes from outside the EU. To define the specific responsibilities of the parties involved, a contract should be in place.

During storage and transportation, conditions should at least be monitored. The sponsor should define the applicable storage (and transport) conditions for the IMPs. When the IMP arrives at the investigator site, IMPs should be stored in a restricted area where appropriate, with ongoing monitoring. Everything should be defined in SOPs.