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Skyepharma overcomes Russian serialisation complexities
Saint-Quentin-Fallavier, France: – Skyepharma Productions S.A.S. (Skyepharma), the French-based fully-formed contract development and manufacturing organisation (CDMO), has extended its serialisation and aggregation service to ‘hard to reach’ countries like Russia and Brazil.
Skyepharma began offering fully serialised and aggregated supplies to Russia from July 1, 2020, to coincide with the introduction of new regulations there.
The service makes Skyepharma distinctive among Western European-based CDMOs, many of whom are not equipped to deal with the new complexities of serving Russian markets. They decided to set up the service after it became clear that many manufacturers do not have the time or capacity to comply with Russian legislation, which differs from EU and North American standards.
In the case of aggregation, Russian regulators demand an international article code, a Foreign Economic Activity Commodity Nomenclature, FEACN (for customs) and a box register serial number.
“The serialisation regulations in Russia are probably the most complex centralised compliance system we have encountered regulation to date,” says Skyepharma, which explains the complexities of serialisation and aggregation in a new blog post (see Resources).
Stand alone or global service
Developing the new service required detailed adaptations by Skyepharma in collaboration with its IT partners Tracelink (serialisation) and Seavision (aggregation).
As a result, Skyepharma is now able to offer similar locally adapted fully serialised and aggregated supplies to Brazil and other developing pharma markets, either as stand-alone services or as part of global agreements that cover the whole value chain of production, alongside packaging and supply chain.
The service is founded on state-of-the-art compliance with leading track & trace standards and allows customers to serve new and highly differentiated markets without relocation or having to set up local operations.
Skyepharma serialisation begins at individual package or box level as part of an overall aggregation process covering the whole supply chain, with packages reconciled in batches, cartons and on pallets, with barcoded labels applied and scanned at each stage.
“Each scan is saved in a database before being passed on to the next participant in the supply chain. In this way, we have a global view of the product throughout the entire supply chain as well as traceability of the processes,” Skyepharma explains.
About Skyepharma Production
Skyepharma Production S.A.S. (Skyepharma) is a specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.
Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.
As an integrated CDMO, The company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.
The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialisation and Aggregation.
Skyepharma also provides a range of support services that help client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.
Further information at: www.skyepharma.fr
Click on Skyepharma Serialisation & Aggregation to read latest blog post.
Skyepharma serialisation is done at box level as part of an aggregation process in which boxes are reconciled in batches, in cartons and then pallets, with labels applied at each stage