Orion operates internationally, and stands out for contract manufacturing services in pharmaceuticals. With four modern plants spread across Finland, the company manufacturers hormonal gels and solutions, small-volume parenterals, tablets, conventional and cytostatic capsules, dry-powder inhalers, creams, and ointments and liquids that include nasals.
As a full-scale pharmaceutical company, Orion has a wealth of experience in providing its contract manufacturing customers with extensive services, ranging from R&D support to regulatory know-how and comprehensive supply chain operations.
Small, virtual and large pharmaceutical companies also use the company for high-profile technology transfer projects, where Orion employs modern and proven project management tools in contract manufacturing. Known for its tailored services, the company becomes a strong partner by striving to meet each customer's specific expectations with excellent and flexible service.
Orion has increased its serialisation capacity at several of its packaging sites and, by using its strong internal know-how, the company is ready to adapt to serialisation requirements that are going to be introduced by governments globally, including the EU's Commission Delegated Regulation (CDR).
The company is preparing for upcoming regulations well in advance, and its strong repertoire of manufacturing and packaging methods has benefitted from an increased capability in serialisation. Orion already delivers serialised products from packaging lines that are capable of serialisation across various markets - including Korea and China - and is looking to update additional lines with serialisation capacities from late 2017.
Orion is on schedule to meet deadlines set by the US, EU and Asian regulatory bodies for serialisation. FDA's regulation has been pushed back from November 2017 to November 2018, and the CDR should take effect from early 2019. Even with these recent changes in the guidance provided by authorities, the company is determined to proceed with its serialisation programme by meeting the original deadlines.
"We started preparing for serialisation several years back, strengthening our internal know-how and capabilities, as well as acquiring the right technical and IT systems. At this point, we are actually ahead of schedule for most markets, including the EU and the US," states Juho Hellmann, development manager for Orion's serialisation project.
"Despite the US deadline being pushed back, we'll still be ready for the original November schedule. In our view, it's better for Orion and our clients to be well prepared for new regulatory requirements than to have to make decisions in haste."
With serialisation, each pharmaceutical product package item is identified with an individual code or other identifier, in order to ensure the reliable authentication of prescription drug items. This is a measure that is needed to fight back against drug counterfeiting, which is a major global threat to public health.
"In the end, serialisation helps to ensure patient safety and this is something that we, as a high-quality pharmaceutical company, care deeply about," says Hellmann. "No patient should miss out on proper care because of counterfeited drugs, and we want to do our best to ensure a fully traceable drug supply chain."
In some markets, extra measures will also be required, including tamper-evident solutions and the serialisation of aggregated shipping packages. Orion is also capable of fulfilling these requirements.
"It's a complex project because the requirements vary between regions, and require a variety of new techniques and capabilities," adds Hellmann.
For Orion's contracting clients, the company's strong capacity for serialisation results in a worry-free future in a regulatory environment that is constantly changing.
"We want to ensure that we have strong serialisation know-how in-house. This way, we can adapt quickly and efficiently to new serialisation needs, and do it in a smart way, so it doesn't eat away at the service level or efficiency of our production," states Hellmann.
