Storage of non-EU manufactured (3rd country) clinical investigational medicinal products waiting for European release for clinical trial.
Added value beyond the physical storage of the IMP/AMP manufactured outside the EU is its complex handling; import release with an approved supplier.
Labelling, and storage in our own facility. Deliveries at short lead times, on time, and on budget.
We have adapted the concerning parts of the GDP guideline. ClinPack provides a temperature-controlled storage area for clinical supply in a 24/7 secured access-controlled facility offering the following services:
- 24/7 monitoring and recording of temperature (2-8°C, 15-25°C) including alarm notification for temperature deviations
- Set-up and maintenance of inventory list, investigational product retrieval management
- Product recall procedure
- Storage in pre-qualified, pre-tempered insulated boxes