Serialization and Standardization: The Challenge

Serialization and Standardization: The Challenge

February 17, 2017PAO-M02-17-NI-002

Serialization is a major challenge for pharma companies and contract manufacturing organizations (CMOs), especially those with multiple sites across many markets. One company that has moved to address it is Sanofi, as Mongi Sakly, from Sanofi’s Global Engineering Support & Services division, and Adriano Fusco, Director of Strategy & Development at its supplier Antares, an Italian-based visual inspection system supplier, explained at Pharmapack in Paris on 1 February.

Sanofi decided to roll out its serialization program transversally across 42 of its sites, possibly rising to over 55, in 21 countries, with a total of 370 lines covering vaccines, OTC drugs, CMO operations and more. The company began the program in 2010, starting in Turkey because it is one of the first countries that is starting to deploy serialization. Many others have followed.

Antares has deployed its site server at Levels 1, 2 and 3 (devices, lines, sites and warehouses) at 31 Sanofi sites so far. Half of the programme should be completed by the end of this year. Antares was chosen – for the first time by a large pharma company - because of its focus on pharma, its expertise in serialization, its high technical competency and agility and the wide range of serialization modules and full platforms available.

“Serialization is a business program, not just an IS or data management program or a server,” Sakly said. “Many different kinds of expertise are needed to implement it, because we have to take into account all the characteristics of each packaging line.”

Sanofi has therefore set up working groups by domain, such as packaging, distribution and validation, to share expertise in packaging, distribution and other key elements, and also to share best practices. All this has been done at global, not site, level. Consistent corporate and the Antares partnership were vital. The company also set an ambitious objective of keeping any loss in original equipment effectiveness (OEE) on any line during implementation to 2%.

“Prioritization was really a key element in order to conduct serialization. Why?” said Sakly. “All of our lines make multiple products for multiple countries. If you go to packaging manager and tell him to stop a line because we need to put the serialization equipment and modules in, he would say ‘No, we can’t just stop, patients are waiting for our products’.”

Unlike past programs and projects, serialization has to be implemented while production continues, with the potential for conflict between them. “This makes for a very tough situation in terms of quality to avoid mix-ups and we need to have all stakeholders involved from the outset to decide on which line to start. It is an extremely complex process.”

Lines must be prioritized with a view to stockpiling product to avoid supply shortages and integrating serialization with a maintenance shutdown. Sanofi treated each line as a sub-project and started to carry out changes on each from end to end, with the involvement of all concerned at the relevant site; otherwise, it could not be done correctly in terms of quality management. Change control, the product portfolio and artworks all needed to be considered in each project in order to keep the shutdown period as short as possible.

The regulatory picture is another major consideration regarding prioritization. As of November 2016, there were over 35 different serialization mandates and others were still emerging. Some of Sanofi’s lines supply Korea, China, the U.S. and Brazil, each with its own regulation. This was something else which needs to be managed correctly in terms of qualification and validation (Q&V).

“Each line has the ability to do serialization only, or serialization plus aggregation but also to do nothing – because some countries are not asking for serialization yet,” said Sakly. “This flexibility is key, and that means when you change your line, qualifying for these three elements to ensure that any mix-ups are avoided when changing from one product to another.”

Sanofi’s solution, in partnership with Antares, has been to implement a common architecture, at four levels: the first and second inside the packaging line, the third being the site server and the fourth a central physical server which receives all the data.

All sites, added Fusco, have not just a standardized mechatronic configuration but standardized cameras and printers. This caused initial challenges but has proved a good strategy, because it enables Sanofi to keep less stock and have a good knowledge of the devices it uses and enables a high level of integration between Levels 2 and 3.

“Imagine the cost in money and FTEs if we let each site do what it wanted in terms of selecting and qualifying a solution,” Sakly said. “Building this strategy of standardization was not easy in terms of project management, so corporate commitment was crucial. Once corporate management agreed the program, we went top-down and told all the sites they had no choice: it was one program, one team, one product from one supplier and one way of working.”

Sanofi established a task force to build a strategy based on this program and way of working, plus standard templates for all qualification documentation and leverage tests based on capitalization, in compliance with corporate quality guidelines and principles Workshops were organized, one in North America and one in Europe, where all the tests needed for a line were examined. At the end, each site manager was able to say how long serialization would take.

This approach had several important benefits, according to Sakly. First, it reduced the business impact of serialization by limiting the shutdown period. It also boosted industrial performance by optimizing the resources of both Sanofi and Antares with respect to the Q&V process. Finally, it provided a common view to regulatory requirements and meant similar Q&V documentation at each site, based on a core technical and quality document that could be adapted to specific site needs.

The project, Sakly added, involved constant communication with stakeholders at weekly meetings, all organised by a steering committee at global level. “Teamwork is not obvious at all,” he observed. “You need to reinforce this way of working. Supply chain team, artwork, production, industrial performance, regulatory, IT, engineering, procurement, quality, finance and Antares, all had to be part of the team.”

Conclusion

The key lesson learned, Sakly concluded, was that the shutdown period for the deployment of serialization on a line must be planned carefully. Installation takes a minimum of six weeks, and some conflict between project mode and production mode is inevitable.

Flexibility is key because of the different potential requirements on each line. Revamping of case packing to deploy aggregation is not at all easy and requires detailed study. However, no impact on OEE was seen from the deployment of serialization. The impact of aggregation on OEE was 1-3% in the first lines  Fusco observed that it can be almost nil but is higher with older lines.

“In terms of maintenance, you need to think long-term,” Sakly concluded. “Centralized knowledge and testing is key, so that you know who is doing what. Executing ones across all sites gives better cost control. Standardizing documentation with our supplier Antares and our strong relationship with them have also helped to keep costs down.”

 

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