Over the past few months, I have conducted research with members of the pharma industry, discussing a wide range of topics. Chief among them was Just-in-Time (JIT) labelling. Many questions surround the worth of JIT – is it really something that simplifies the labelling process? Or is it just another overrated method? Given recent developments on global inspections, JIT labelling could be the answer you were looking for.
After having prepared a vast network of suppliers from across the globe, naturally each country possesses different regulatory needs, therefore sponsors must account for those requirements in their clinical label. This could be incredibly beneficial – if the IMP is to enter 10 different countries at the same time, and the booklet labels aren’t available, this could mean an extremely long label containing an excessive number of differing languages.
This has created a huge problem, as the ultimate desire is to have a label that contains the language specific to a certain country. How can companies therefore maximize the use of their product then? How can sponsors dispense of it and move it more quickly? By delaying product configuration, taking action by country or by study, your clinical labelling process should be completed as late as possible, to achieve a greater level of flexibility. This could become a common manufacturing process.
However, bear in mind, with various pieces at play on the board, much can go wrong if left unaccounted for. For that reason, finding the key to success could prove complicated and in some cases, the extra workload could delay the whole process. It could be thought that the JIT method is not exactly the panacea, but it may be a solution in extreme cases.
For instance, if working on a lean packaging project for a trial, can JIT help in releasing drugs more efficiently in a matter of days? Or what if there are 200 packages sent to many different corners around the world, and each country needs its corresponding paperwork to be filled. It could become very risky and time consuming as someone in the relevant department would have to explain all of the needed requirements to someone else, who may have a totally different professional culture. This could mean that then, after releasing the drug, many oversight steps should be taken. In recent times, the idea of using recognized symbols in lieu of languages has been touted as a solution. This could save significant time, as with symbols arguably little could left open to interpretation. But whether they are ultimately the answer, only time will tell.