Case Study

Managing Risks To Time Critical Product Imports At Clinical Supply Depots

Packaging

A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based in the US and the investigational medical product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU.

This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements. With seamless communication between Catalent and the Israeli depot team, the customer’s study was able to start on time and support patient screening timelines.

The Challenge

The customer first notified Catalent that they would like to use the Catalent-managed and audited clinical trial depot in Israel to support their study, which was planned to start in two weeks after the arrival of the shipment. The customer was unaware that all clinical trial products entering Israel must be QP released within a clinical trial depot and could not reuse their EU QP acceptance. While the EU QP release is reviewed and is a supporting document for the Israel QP, it alone does not constitute Israel QP release.

Upon reviewing the customer’s requirements, Catalent noticed that the customer had failed to prepare the required paperwork nor account for the time needed for the QP release process in Israel, which typically can take up to three to four weeks. The customer’s clinical trial timeline became at risk considering the now complicated process for obtaining QP release.

The Catalent Solution

Recognizing the urgency of the situation, Catalent sent the customer a checklist of how to prepare their product shipment, fill out the proper documentation and meet the requirements for standard warning labels per Article 14 section 9.1.2.

Along with the checklist and documents, Catalent provided detailed instructions, the forms and tips for meeting the Israel-specific QP requirements. Based on past experience, Catalent knew that the most common error was not having the following warning information on the label that said ‘’For Clinical Trials Use Only’’ written in four languages: Hebrew, English, Arabic, and Russian. Catalent also worked to ensure that the customer understood the detailed requirements for other common errors that could lead to significant delays.

While the customer completed the required documentation, Catalent worked with their contracted depot to create an action plan outlining the steps needed to meet the Israeli Ministry of Health requirements.

Concerning the product label, Catalent advised the customer to have the product label proofread and amended, as needed, by the local Israeli QP prior to production to ensure compliance with local Israeli regulations.

Conclusion

The customer benefited from the Catalent team’s 10 years of experience managing more than 1000 protocols in Israel. Catalent applied their in-country expertise and was equipped to offer valuable resources to the customer, drastically reducing the typical Israeli QP approval time from three to four weeks to just ten working days.

By allowing Catalent and the depot to apply for the import license for the product and facilitating the QP’s pre-approval the label of the imported product – before going to production – the customer also saved costs. This proactive process ensured the label was not rejected during the QP release process, another critical step in avoiding amendments or applying additional labels on site at the depot.

Leveraging long-standing relationships with their Israeli depots, Catalent enabled the customer to experience a faster, more-efficient QP approval process – a crucial factor in starting their study on time and within budget.