Pharmaceutical supply chains are becoming ever more complex, involving an increasing number of external partners. This week, I want to speak about the external partners that might be involved in an artwork related drug recall and how pharma organisations can work effectively with them to minimise the risks involved. We saw in the last Artwork 101 post the main actions to do when the error has been spotted externally to the company. The implications of an artwork error can be as far-reaching and serious as any other error with the supplied product. In a recall situation you will likely have to work with a range of external partners to carry out the corrective actions required to recall the product and resupply the market and the preventative actions required to address the root causes of the failure.
There are a number of external partners involved who have unique roles to play
Joint ventures, local external marketing companies and local distributors: Many pharmaceutical companies work with local partners in different countries around the world to market their product in that local country. In a recall situation, these local companies may be the main point of contact to the impacted customers in that local market and also to the local Health Authority. Therefore they have a key role in maintaining relationships with customers and regulators. Your company is likely to have well defined recall processes that would be invoked for an artwork related error and these local partners will have communication roles to play within these processes.
Artworks will need to be updated to resupply the market and these local partners will likely have to be involved in definition and approval of these new artworks.
When assessing the root causes of the incident and the preventative actions required, the end-to-end process for artwork definition and approval through these external parties must be considered. How robust are these processes and how well have you trained your partners?
Wholesalers and Distribution partners: These are the operations that move product through your supply chains. They will be involved in the corrective actions, quarantining and returning product and supplying new product to the market. Again this should be through your company’s standard recall and resupply processes.
Contract Packaging Operations and Printed Packaging Suppliers: Most pharmaceutical companies use external partners to manufacture packaging materials and to pack product. Like the above, these partners will be involved in recalling and resupplying the market, quarantining incorrect packaging materials and packed product in their inventories, manufacturing new packaging materials and repacking impacted product where feasible. They will also be involved in the approval and quality control of the artwork on the resupplied packaging materials.
The end-to-end process again needs to be reviewed when assessing root causes to ensure the effectiveness of the artwork process steps undertaken by these partners.
External Graphics/Artwork providers: You may use external agencies for artwork creation. Revised artworks will be required and likely with some urgency. You need to ensure that rigor is maintained to avoid errors occurring when people are in a rush situation. As with the previous partners, assess the end-to-end process through these artwork partners to ensure that the root causes of the error are identified.
Clear processes that are well understood by your partners
A recall is an event that any pharma company wants to avoid. It risks the well-being of the patient, places a burden on healthcare providers and causes unnecessary disruption to customers. However mistakes do happen and therefore it is essential to ensure that there are clear effective processes across the extended supply chain to manage the recall, revise the artwork, resupply the market and ensure that the root cause of the error is eliminated so it is prevented from happening again. Working closely with your external partners is key in ensuring a controlled outcome.
To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.