How can pharmaceuticals manufacturers and packaging service providers manage to meet the regulations for serialisation by 2019 and issue globally unique serial numbers?
The launch of serialisation is a major and far-reaching task for all pharmaceutical packaging operations. With regard to unique serial numbers the question is whether these should be generated centrally or decentrally. Initially, the serial numbers are created in a database according to a selected algorithm and these numbers are then distributed from the central point to the production locations and from there on to the individual packaging lines. With decentralised generation of the serial numbers each location and each packaging line is given unique, alphanumerical coding which is then channelled into the serial numbers algorithmically. This means unique serial numbers can be achieved even when they are issued decentrally. How long does it take to retrofit packaging lines in line with serialisation requirements?
Technical retrofitting can be achieved within a few weeks. For an initial pilot line the entire timeline can easily take two years as it may, under some circumstances, be necessary to redesign the packaging and make changes to packaging material approval. What happens if the relevant guideline changes or if there are new regulations?
Can existing serialisation systems react efficiently? Indeed, it pays off for pharmaceutical companies to look to a manufacturer that has programmed the database application generically. In this case operators can themselves define the structure of the codes with the number and type of data fields. This makes it possible to carry out adjustments using parameterisation instead of programming and thus the manufacturer having to replace entire software packages. Replacement of entire software packages generally not only entails the qualification and validation of the new product but also the revalidation of all functions already previously in use which could be affected. In our serialisation software MEDTRACKER
all principles that are already in force or are expected, are already implemented and can be adapted to the country-specific regulation or specificities with little expense/effort. Thanks to the modular system architecture the expense/effort of validation remains reasonable with smaller, subsequent adjustments. It is possible that the information to feature on the packaging might change from time to time. Late Stage Customisation is the solution here. Can you explain the term?
It is not to be expected that the Delegated Act (EU) 2016/161, i.e. the data fields and type of the coding, will change. It is much more the case that the countries might occasionally change coding regulations, be this in terms of text changes, new requirements or changes to prescribed symbols. The term Late Stage Customisation relates to printing the packaging as close as possible to the delivery date, generally with the aim of being able to realise small batches, for instance country-specific packaging, as cheaply as possible. Printing is carried out using a digital process that, amongst others, can also perform serialisation. Another very positive side effect: this philosophy makes it possible to react very quickly and effectively to altered labelling regulations. Stock levels do not need to be reprocessed because these are generic and country-neutral in any case. The pre-requisite for this rationalisation benefit is the already mentioned generation of generic packaging that ideally contains all country-specific data on the side of the box.