Massimo De Carlo is the Global Supply Chain Quality System Manager for F. Hoffmann La Roche and his area of responsibility includes the global quality requirements for Artwork Management and Serialisation. In his role he also leads the quality community in the related project.
He joined Pharma IQ recently to explain the new global artwork change management process & system at Roche and how this was developed from an analysis of the known errors and business needs.
Pharma IQ: Could you perhaps start by explaining the main challenges around artwork control systems and packaging technologies at Roche?
M De Carlo: The main challenges are around the regulatory requirements, expectations and locally established processes in different countries and regions, which lead to a very high complexity of the legacy business process. When implementing a global system for artwork change management, we have selected a phased approach.
In the first phase we decided to implement a system for all changes managed in one of our global artwork centres. In later phases purely locally managed artworks, mostly relabeling activities, will be integrated
Pharma IQ: Can you explain what a new global artwork change management system looks like?
M De Carlo: The chosen solution in our case is a workflow business process management software. This workflow supports the business steps and the quality steps globally end-to-end, from starting the manuscript to the final release of the finished goods which contain the changed artwork.In our case we opted for an SAP Solution.
Pharma IQ: What does a good quality control plan for artwork change management look like and what are the specific challenges around that?
M De Carlo: The most important point in the quality control plan for artwork change management is that we make sure that all regulatory and quality properties impacted by an artwork change are considered. The objective is that we have all these quality relevant properties under appropriate control. We also set the standard that these properties need to be checked at least twice from the beginning to the end of each change. With this approach the increased control in some cases is compensated by the transparency and the fact that some actors may rely on controls already performed ,avoiding excessive controls.
Pharma IQ: What are the main artwork errors experienced by most companies, including Roche?
M De Carlo: We did a deep analysis of the errors in this area and our conclusion is that the main category of error we had is originating in the artwork creation steps, this means the generation of a proof starting from a manuscript. Our experience is that during these steps some unexpected changes with a deletion or addition of text happened, which are not actually corresponding to the change request. This was the most common category in our case at project start.
Basically, the most common artwork errors category fully depends on the specific processes of a company. We implemented numerous actions in order to address the main category of errors we experienced and now we see that, together with a drastic reduction of the error overall rate, the weight of the single root cause classes changed and we measure a higher percentage of errors which are already present in the manuscript as the source text.
Pharma IQ: What key process elements, for example regulatory compliance versus supply chain timelines, need to be put in place to achieve successful artwork?
M De Carlo: Tthe key element for us in the process is that the artwork change needs to be assessed, checked and approved only in the context of some artwork relevant properties of the finished goods. This generated a new concept of Bill of Artwork, which is a subset of the finished good properties, which are artwork relevant and are owned by the regulatory function responsible for the receiving country. These data are all presented together for assessment, check and approval at the different steps of the workflow.
Pharma IQ: With regard to the Falsified Medicines Directive and looking ahead to the Delegated Acts, how has your organisation been impacted by this imposed legislation and are you dealing with any challenges around this?
M De Carlo: Roche has been impacted by the new legislation, absolutely. This is really a big change which will need to be implemented in the next few years. we are actually working proactively on establishing a strategy within the company, of course, and aligning globally in order to have one standard which will fulfil the Falsified Directive for the European Union as well as possibly upcoming directives and legislation from other countries. And this is of course a big topic regarding artwork change management. The new process and system for Artwork Change Management were developed taking into consideration the upcoming changes due to the Falsified Medicine Directive
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