[Charlotte Van Hoorde]

Reply To: JIT Labeling (Vials in Cartons)

Based on the provided information, the labeling activity involving both primary and secondary receptacles, along with applying the tamper-evident (TE) seal on the kit, can indeed be executed Just in Time (JIT), just prior to distribution.
It’s noteworthy that since the label contains protocol information, a full QP release in the EU would be necessary, as this information on the kit is not considered as an ancillary label only.
For certain vendors, such labelling activity would typically be termed as “On-Demand” packaging, involving a full batch review and release within the process itself.

This approach offers a significant advantage in stock assignment. By assigning stock only at the last moment, it allows for greater flexibility. Stock isn’t allocated to a specific study/protocol from the start, which proves immensely useful, especially in cases of product scarcity or when dealing with expensive products in clinical trials. This flexibility ensures optimal resource allocation and minimizes the risk of product wastage or shortages, ultimately enhancing efficiency and cost-effectiveness in clinical trial operations.

Working closely with experienced vendors can facilitate the implementation of such JIT labeling processes while ensuring compliance with regulatory standards and operational efficiency.