Artwork errors are an ongoing risk in a Pharma organization. I already listed the different types of errors you can have in my blog post Excellent Packaging Artwork Capabilities 2 – Consequences of errors, and whilst a number of errors present minimal risk to the safety of the patient, for example non-consistent spacing between paragraphs, others can have a major impact such as putting a wrong dosage on the packaging. In this blog we discuss the different approaches required depending on where in the supply chain the error is spotted.
The artwork errors can be detected two ways. They can be spotted internally at the various verifications through the supply chain or they can be identified externally, for example by a healthcare provider. Each case leads to specific actions to correct the issue to minimise the impact and to prevent the issue happening again. Here some of the priority actions that should be integrated very quickly after the incident.
When the error is spotted internally
- Key Quality and Operational personnel have to be informed to decide on corrective actions that need to be taken to address the quality issues with products.
- The affected product and all associated components held in inventory must be quarantined
- The Quality function has to make appropriate decisions about the severity of the error, whether the incorrect components can be used or not, and if the product can be released or will require rework with revised packaging components.
- Once the immediate supply issue has been resolved, a more thorough investigation should be conducted to determine the root cause and learn from the incident to stop it happening again.
When the error is spotted externally
Recall from the external marketplace is obviously a complex activity requiring significant communication to ensure the safety of the patient is protected:
- The organisation should have robust communication mechanisms as the error could be conveyed through local country operations, customer service help-lines or even through local county Regulators.
- As the product is already out in the supply chain, the first steps of the company communication would include the impacted local Regulatory authorities and an assessment of the error to determine what level of recall is appropriate.
The scope of the recall can vary from a wholesaler level right through to patient level. This has an obvious impact on the patient and healthcare professional’s trust in the product and the company. An immediate comprehensive response is key to address the error and minimise its impact on the patient. As described with internally discovered errors, there then follows a series of corrective actions to resupply the marketplace and preventative actions to ensure the root causes of the incident are identified and addressed to prevent reoccurrence.
In my next post I will discuss on how to work effectively with your external partners to minimize the impact of a drug recall.
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.