IMPs: Applicability of the GDP-Guidelines
The European Medicines Agency (EMA) published a draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products (IMPs) for human use for comment. Comment Deadline is August 31, 2018.
The proposed guideline lays down the principles for the two-step release procedure, responsibilities of the Qualified Person (QP) and the Sponsor and also for IMP shipments. It should be ensured that "the shipping of the IMPs minimises any risk". Therefore, "the applicable elements" of the GDP-Guidelines should be taken into consideration.
What is needed?
The draft also gives guidance on what to have in place when shipping IMPs:
- Shipping order and respective instructions
- Temperature control and monitoring of the storage conditions
- Records of storage conditions
- Specified conditions during shipment if necessary
- Investigations of deviations
- A detailed inventory of the shipments (including addressees' identification)
- SOPs for site to site transfers (however, "transfers of IMPs from one trial site to another should remain the exception"!)
- Review of product history (for example, trial monitoring reports and records of storage conditions)
"The responsibility for the control of the IMPs shipment remains with the sponsor (or representative) until it has been received and accepted by the clinical investigator site or pharmacy, where applicable."
Find out more in the Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice issued for commenting.