Meet the rigorous labeling requirements associated with clinical trials for investigational medicinal products (IMPs) with precision and agility.
Printing and verifying labels for investigational medicinal products (IMPs) used in clinical trials is challenging. But with subject safety, regulatory compliance, track and trace needs, and the integrity of clinical trial data on the line, there is no room for labelling errors.
The EU labelling regulations for investigational medicinal products (IMPs) used in clinical trials are stringent. Complying with them can be complex and costly due to the many factors that can affect label content. Among them: the design, phase, and location of the clinical trial; changes in dosage, expiry dates, and other label components that arise between or during clinical trials; and country-specific language requirements.
Die T11 Manual Mark & Verify, part of the Systech/PCE line of track and trace solutions, helps overcome the challenges with a cost-effective, all-in-one solution for printing and verifying labels for IMPs used in clinical trials. Flexible, adaptable, and reliable, it ensures all required label information is present, legible and accurate—helping to maintain subject safety and data integrity and meet compliance requirements.
Although IMP label batch sizes can increase from one clinical phase to the next, they are still typically small. Frequent changes to label content often necessitate just-in-time printing and verification necessary.
Cost considerations, limited usage, and insufficient space make investing in an onsite, large-scale labelling system impractical. Outsourcing label production and verification or tying up an existing on-premises system for short print runs can be expensive as well as inefficient.
The T11 offers a cost-effective alternative. It integrates agile printing and precise verification capabilities in a single, multi-use solution.
Featuring an ergonomic, space-saving design, the T11 can be used in small, confined environments. It fits on a tabletop or cart, so it can easily be moved to different sites as needed. It also offers capabilities that enable it to be used for label serialization to track and trace IMPs throughout the clinical trial lifecycle, as well as for IMP labeling.
The T11’s flexibility enables it to quickly print and verify label content. That includes the IMP label requirements specified in the Verordnung 536/2014 der Europäischen Union über klinische Prüfungen (EU CTR), which went into effect the end of January 2022 and replaces the Richtlinie der Europäischen Union über klinische Prüfungen (EU CTD) 2001/20/EG..
Clinical trials submitted under EU CTR must comply with the new requirements. Existing clinical trials authorized under EU CTD may retain their original labelling. The T11 can accommodate whichever regulatory framework applies, as well as any label changes that arise.
It supports variable formats to handle the precise content that must appear on IMP labels. Simply supply the approved EU CTR-compliant label content, which is then dynamically assigned to PDF templates. As labels are printed, the T11’s integrated camera verifies their accuracy against the approved PDF.
While the EU CTR standardizes most content for labels on IMPs used in clinical trials, labels must be written in the local language of the trial site, as well as in any additional languages required by local regulations. Labels on IMPs used in clinical trials still operating under the EU-CTD may also be subject to other country-specific or local requirements.
The T11 can quickly adapt to the labeling requirements of individual countries, as well as clinical trial sites. All that is required is a customer-approved label PDF proof.
The T11 can also run in peel-off mode for just-in-time printing with label verification for quick relabeling or additional labelling needs that may occur due to country- or site-specific requirements. Rewind mode is available to produce approved labels for later reel-to-reel application.
The T11 comes with two integrated camera options — a smart camera or a high-resolution camera — to provide optimal verification of label information depending on label size and print resolution. Both can be used for three types of verification: presence check, quality check and reference check.
As labels are printed, the camera compares each label to a PDF of the customer-approved label to confirm that all required information is present, legible, and correct. If an error is detected, the operator is notified and must confirm the faulty label has been removed before the system continues production.
In addition, the optional PCE Line Manager (PLM) software can display where defects originate so they can be mitigated. The T11’s precise vision inspection capabilities also help ensure accuracy when used with software for label serialization.
Discover how the T11 Manual Mark & Verify combines efficiency and affordability, transforming the way labels are printed and verified for use on IMPs in clinical trials.
Producing clinical trials labels is fraught with challenges. The first step to overcoming them is to understand them.
T11 Mark & Verify offers a cost-effective solution for printing and verifying labels for the IMPs used in clinical trials
From frequent label changes to just-in-time printing needs, producing and verifying labels for use in clinical trials can be complicated.
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