New EU clinical trial guidelines lays down the principles for the two-step release procedure

The proposed guideline lays down the principles for the two-step release procedure, It concerns the responsibilities of the Qualified Person (QP) and the Sponsor and also for handling and shipping of investigational medicinal products for human use.

The guideline states that IMPs will remain under the control of the sponsor until a two-step procedure is completed. This consists of: 

• The batch certification by the QP.
• The regulatory release by the sponsor for use in a clinical trial.

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The guideline also states that regulatory release of the investigational medicinal product by the sponsor should verify that any aspects required for compliance with clinical trials are in place before IMPs are shipped to the clinical investigator sites.

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With reference to shipping, the guide states "it should be ensured that the shipping of investigational medicinal products minimizes any risk while ensuring that the quality of the product is maintained and the applicable elements of guidelines on Good Distribution Practice of medicinal products for human use are taken into consideration."

Here are the key areas covered:

• 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).

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Additional areas of concern covered by the guideline include deviations from the specific conditions during the shipment. In these instances, a full investigation will occur and full responsibility will remain with the sponsor. The guideline also covers contractual arrangements between the manufacturer and the trial sponsor, stating that the "responsibilities of the manufacturer and sponsor should be appropriately defined, agreed and   controlled in a written contract."

Click here to take a look at the new guideline in full