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Booklet labels or Just-In-Time labelling: A question of standards

Published date: 
07/09/2017

Pharmaceutical companies are multiplying their efforts to establish just-in-time labeling. For Anthony Morrow, Business Development Manager Northern Europe at Faubel, this is only feasible if it can be assumed that all trial participants such as sites, clinical trial monitors, local depots, regional distribution centers and, ultimately, contract manufacturing organizations share the same high quality standards.

Ideal vs. reality

Ideally, verum, placebo and comparator drug arrive at the depot where they will only be labeled as needed before being directly shipped to the trial site or even to the subject or patient. "The process sounds simple, but there are still many uncertainties to resolve", admits Morrow. There are plenty of questions that need answering: Among others, are IMPs still unmarked when they arrive at the depot? Does the depot have skilled staff that is able to carry out printing and application according to GMP? Are air-conditioned storage areas available for IMPs and bulk goods? If one of these prerequisites is not met, there may be unpredictable disruptions within the supply chain“, he explains.

High standards

Therefore Anthony Morrow does not expect that standards required for just-in-time labeling can be implemented in every single depot and every single participating country: "But it is unrealistic to think that depots can quickly catch up with the standards of secondary packaging manufacturers and CMOs."

In the transition period, just-in-time labeling just cannot come close to the quality of conventional labeling. Booklet labels are irreplaceable for small containers such as vials. When it comes to blinding, cooperating with a label specialist is the most effective way to proceed. “Both processes have their place and will continue to exist in parallel. In recent concepts, analog and digital elements are combined in booklet labels. Such hybrids also make late stage customization possible.”

Contact: Miriam Hüther

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