Serialization workshop: helping you to kick-start your project
Serialization is not just a machine to install, it also requires management software up to the ERP level and connection to the cloud services, such as European Medicines Verification System (EMVS), and to logistics/warehouse companies. The production line may also need an upgrade to facilitate the serialization process. As many clients need help already in pre-project phase, in making the User Requirements Specification (URS), we provide consultancy services and serialization workshops for pharma industry.
With the US serialization deadline for pharmaceuticals looming in the coming November and the EU deadline in two years, the pharmaceutical industry has hands full of work. The developments in China, Brazil, and Russia add to the workload.
The big pharma is generally well into the projects, with roll-up of serialization on line after line. Consultants have been employed and dedicated personnel at serialization software and hardware providers reserved. The medium-small pharma as well as CMO industry has also woken up. Some of the medium-sized enterprises started their projects in a good time, but many are only now looking for help.
A cross-functional steering team is needed
The complexity of the pharmaceutical serialization projects means that a cross-functional steering team is needed: RA, QA, IT, production, factory management, as well as artwork design management. A C-level project owner is needed to keep the project at top priority.
The markets that the products are supplied to must be assessed. Even if the market is European Economic Area (EEA) + Switzerland only, there are regional differences, apart from the obvious language requirements, that need to be heeded. Some countries, such as Germany, France or Spain, may require the national reimbursement code, some have other quirks: Finland, for example, will continue to require the Nordisk Varenummer (VNR) number which is somewhat similar to the reimbursement codes, only not in the Datamatrix, but on the product package.
A serialization solution that has been well-tested in the industry is needed to ensure that all the necessary regulations are adhered to. One must also note that the division of medicines into the Rx and OTC varies between countries, and is subject to change. There may also exist local blacklists of OTC drugs requiring serialization.
The best serialization strategy for you
Servicepoint offers consulting services to define the best serialization strategy for you and to implement your automation and serialization projects. We also closely monitor the development of legislation in the European Union, Russia, and other markets to be able to guide you through the relevant serialization regulation.
In serialization workshops we provide project leaders and stakeholders a solid background on regulatory serialization requirements, industry experiences on serialization and best practices, as well
as help in drafting the user requirements specification (URS).
For the past 30 years our core business has been to design, manufacture and install & integrate new and to retrofit existing production lines
— as well as maintaining them.
We provide you also with an overview on how a serialization project usually proceeds, from your perspective. As an experienced integrator of automation systems, we can provide you with the background needed to make informed decisions from the packaging line hardware up to your ERP system.
We can also assess your production lines, the products and their market areas, your customers’ needs, and the applicable regulatory requirements to produce first order investment cost estimates valued against the profitability. We can also evaluate your packaging lines, and prepare draft plans on where and how to retrofit the serialization equipment and how to upgrade the packaging lines for extra capacity.
More resources for you to concentrate on your core business operations
We do, however, much more than consulting. For the past 30 years our core business has been to design, manufacture and install & integrate new and to retrofit existing production lines — as well as maintaining them. Therefore we can carry out the whole serialization project for you. With the help of our multi-skilled serialization team, you can concentrate your resources on your core business. Give us a call and book us for a workshop — let’s kick-start your serialization project!
Give us a call and book us for a workshop — let’s kick-start your serialization project!
Next workshop will be in 1.3.2017 in parallel to CIS Pharmaceutical Forum. Read more
Servicepoint Kuopio Oy
+358 44 7868 215