Securing the supply chain
Pharma’s supply chain can be very complex.
Importation of the drug product
As previously discussed, all pharmaceutical products manufactured outside of Europe must be analysed in line with the specification
outlined in the product’s MAA upon entry into the EU.
In addition, depending on the composition of the pharmaceutical drug product, importation duties and taxes can vary significantly
and add to the overall supply chain cost. By assessing the drug product and the manufacturing processes of the product, it
may be possible to apply a specific customs procedure to minimise, or even eradicate, duties payable. For example, we have
used this approach for a number of high-value biologic APIs being shipped into Europe by US clients.
Securing the supply chain and ensuring traceability
With the increasing problem of counterfeit, misbranded, adulterated and diverted drugs entering the supply chain, it is essential
to ensure full traceability of the drug product by seeking advice on the country specific requirements and then implementing
an anti-counterfeiting strategy, such as serialisation or 2D matrix barcodes. For example, it is useful for service providers
to be able to apply and verify 2D codes to packs, including on-line verification of 2D code quality (ISO/IEC15415) standard)
and content. At our company, we can also receive and/or generate serial numbers and apply these within the code and verify
on-line. This includes aggregation to shipper and pallet level, and the management of the data and collation thereof for supply
to the client.
Distribution strategies for the drug product
Traditionally, client companies would have their drug product manufactured at a CMO and then the finished goods would be shipped
to a wholesaler for storage and distribution. To mitigate risk, cost and shorten the supply chain, many client companies are
now using CMOs that provide third party logistics services to reach their target market end users.
When deciding upon a distribution strategy, the CMO, in conjunction with the client company, must conduct a distribution risk
assessment that considers factors such as product value, transit times to target markets and temperature requirements. Results
from the risk assessment should then be written into the distribution instructions to ensure consistency and repeatability
in all activities for every product dispatched.
To ensure all drug products reach the end user in optimum condition, the CMO should conduct a full validation of shipping
and packaging configurations. For example, our validation and logistics teams work with the client company, the packaging
supplier and distribution partners to design a configuration bespoke to the drug product being shipped. We also develop and
execute a full validation programme to ensure the solution is fit for purpose. This can be extended to include route qualification
where ‘dummy’ shipments can be made to test the performance of the system in transit.
Additionally, it is helpful to find a service provider that can identify paperwork requirements in relation to import, export
and customs documentation early in the project to ensure there will be no delays at shipment.
Finally, one of the most important aspects of successfully launching a drug product onto the European marketplace is, quite
simply, good project management. Having a detailed, realistic project plan and an experienced and dedicated product supply
manager are the keys to success.