The number of pharmaceutical product recalls are growing. Some estimates show that over 50% of recalls are related to pharmaceutical packaging artwork and labelling.
How many times have we heard these statistics over the last 20 years? And yet nothing changes.
The bottom line is that if there is an error with pharmaceutical artwork, the patient can die. The absence of regulatory requirements within the pharmaceutical industry regarding the production of artwork is indicative of the lack of focus often given to this process.
There is increased pressure to improve operational performances and reduce the level of human error. If we make it easy for someone to make a mistake, they will. We need to make it easy to get it right first time.
To do this we have to take a realistic look at the challenges faced by the pharmaceutical industry over the next five to ten years which will impact the artwork process and determine what robust innovative measures we should take to ensure these recall figures don’t spiral out of control.
Attitudes towards artwork management within the supply chain need to change. There should be a focus on quality driven systems to enable continuous technological developments facilitate the automation and standardisation required to prevent mistakes.
Firstly we need to look at some of the key aspects of the pharmaceutical industry that are driving change.
1. Mergers & Acquisitions in the healthcare sector set a new record in 2015 of $724 billion. As a result, the agile and secure management of digital artwork assets has become a key strategic focus.
2. Serialisation will result in a combination of more artwork content and stricter directives governing readability. This combined with reduced print space will drive an unprecedented demand for regulated artwork services and management systems over the next 5 years.
3. Product proliferation leads to significantly increased frequency of artworking events and far greater complexities in managing the artworking processes with many companies having reached or exceeded their capability to manage the process internally.
4. As a result of the patent cliff, a single innovative pharmaceutical product which has lost patent protection is being replaced with new generic products globally, leading to an exponential growth in demand for outsourced artwork solutions.
What needs to be done?
Why do we accept high levels of inaccuracy when we can standardise how artwork is created and automate how it’s managed?
Pharmaceutical companies need to understand how their present artwork processes should change to facilitate these future drivers. To navigate accurately through these changes a proactive and systematic approach to artwork is crucial. Companies have to ask themselves if the artwork process is clearly defined, optimised and quality driven.
Managing artwork for the pharmaceutical industry is a very specialised, niche service which can only be properly controlled by a GMP compliant partner. If using a vendor, it is critical to develop a partnership to ensure all aspects of the artwork supply chain are controlled and agile to meet the challenges of the industry.
The two fundamental areas which need to be addressed are the physical production of the artwork and the management of the artwork process.
Perigord recommends a one touch process in building compliant artwork which increases efficiency, reduces costs and minimises risk through fewer stages, thus eliminating the historical prepress stage. Effectively this means that artwork is built to high quality standards (and print ready) and the layer structure and font integrity is maintained throughout the approval cycle. Perigord ensures this process sits in a robust quality management system with a change management procedure that facilitates the efficiencies to be gained through the introduction of automated technology.
Artwork management systems
The most obvious way to remove the dangers of human error is to automate. Managing the amount of stakeholders and the input they have in this complex process by email is inconsistent with every company’s objective of getting product to market on time and right first time. This needs to be replaced by a highly configurable system that can be easily adapted to align with a customer's current and future processes, giving the flexibility of a systematic approach to managing products and product related information.
In summary, reducing the number of recalls in the pharmaceutical industry requires better regulation, improved operational procedures and a change of attitude towards artwork production and management. The challenges that lie ahead have been identified, all we need now is to face them head on, in a controlled GMP fashion.