Sheraton Skyline hotel – 30 March 2016, London
Yesterday I had the opportunity to attend a one-day Serialisation conference – CMO Seminar UK – Proactive Strategies for Track and Trace Deployment. Organised by Optel Vision, TraceLink and Be4ward, the objective of the conference was to help explain the requirements of Serialisation to CMO organisations and provide guidance on how to approach their Serialisation implementations. Speakers presented on a range of topics, including:
Serialisation implementation from a CMO perspective
Dave Hodgson, Technical Director, Central Pharma Ltd
Dave presented on the learnings Central Pharma have gained through their serialisation deployment activities. Supplying over 60 markets worldwide with Pharmaceuticals and Nutraceuticals, Central Pharma are proving serialised products to China and India.
A key learning was understanding that some of the service providers were learning about the technologies and the market place, so early projects were as much a learning experience for the service providers as Central Pharma. This impacted both timelines and the quality of advice from the provider. Some of the technical solutions that were planned proved infeasible, for example it was planned to use much of the existing line printing equipment, but new equipment was actually required. Selection of scanning equipment also proved challenging due to the range of solutions with widely varying technical capabilities available.
Dave emphasised that having a clear IT strategy is important to ensure that data flows, data handling, response times, and file formats are all adequately considered. Requirements to link with other sites and customers also need to be defined and agreed. User Requirement Specifications need to ensure that all requirements have been accurately captured, e.g. serialisation number formats and character lengths. If not, there is a risk that chosen equipment and systems will not meet the detail of your requirements and result in costly and time-consuming rework.
Implementing Serialisation Pilot Project
Aladin Alkhawam, Director, Packaging, Par Pharmaceutical
Aladin presented on Par’s experience with their Serialisation implementation to meet the US Track and Trace requirements. This legislation is some of the most stringent serialisation legislation in the world.
Par established their programme in mid-2014. They were particularly concerned about the availability of skilled resource. They also only wanted to impact lines only once, so needed to implement serialisation and aggregation in one go.
They realised that Serialisation impacts every part of the company, so established cross-functional governance and a cross-functional programme team to help develop their strategy and funding approach. Solutions are expensive with little return on investment, but you have to comply to continue to supply impacted markets.
They undertook a pilot on a single packing line to learn about what they needed to do and what issues would have to be addressed to support a global roll-out. From April this year, Par will have a packing line go live every month for 18 months. This takes resource and also careful planning to minimise downtime. Selection of experienced appropriate partners is also seen as essential to support this programme.
They have also planned the cutover of SKUs to meet the plan as artwork will have to be updated and new components provided. The recent Endo acquisition for Par requires all artwork to be changed, so this has allowed them to consolidate changes. They also have to update their batch records to account for serialised product.
They have introduced measuring OEE to understand the impact on line efficiency, as research they have done across the industry indicates impacts of 30-40%, although much of this can be recovered as operators become familiar with the new technologies and processes.
Track and Trace implementation and Merck’s “CMO onboarding programme”
Gert Vieugels, Global Program Manager, Track and Trace, Merck KGaA
Gert’s presentation covered the work that Merck is doing to implement Serialisation, particularly in their CMOs.
From 2011 to 2014 there were 264 product issues reported through Corporate Security in Merck and thus this programme is seen as a key part of assuring patient safety. Through current known legislative requirements, 75-80% of all Merck SKUs will have to be serialised by 2019.
The Serialisation programme is part of an overall product security strategy and was launched in late 2013. Roll-out is planned to be complete in 2018. Scope includes all Merck facilities and CMOs. A cross-functional Steering Team and Programme Team is in place. Whilst seen as a compliance programme, it is also seen as a platform for brand protection, patient support and information provision.
30 internal lines are now complete with a further 35 to go. 70 CMOs need to be integrated before 2019. Implementation in CMOs will be challenging due to differing IT systems, levels of knowledge in CMOs and contractual obligations. System integration will be via TraceLink and serialisation numbers will be managed and provided by Merck. The CMO stream is working on assessing status with CMOs, educating and developing integration templates. They are also working on risk mitigation strategies and pruning of the CMO supply base. CMOs need to be prepared for Serialisation if they want to remain as suppliers.
There is a wide variation in the level of preparation and maturity across the CMOs, with many reluctant to do anything until they get clear messages from their customers. Implementation takes time and so CMOs need to be careful that they ensure they have time for installing required equipment and implement required changes to processes.
Regulations, Requirements and Standards for Europe
Philip James-Bailey, Industry Development Manager, GS1 UK Healthcare
Philip presented on GS1’s activities in setting standards and building partnerships for coding solutions. He explained the requirements of the EU FMD legislation and the GS1 global system of standards – how barcodes are constructed and what content is held in each. For FMD, barcodes need to hold the product code, serial number, batch number and expiry date in the code.
The GS1 system provides benefit by providing a set of standards across the value chain to the patient.
Developing a Serialisation Strategy
Stephen McIndoe, VP, Be4ward Ltd
Stephen presented an overview of serialisation requirements and what a CMO would need to do to comply. He explained the typical models for product coding, serialisation and track and trace. He also discussed the requirements for coding and aggregation equipment to be installed on packing lines and the IT requirements to link lines to the enterprise-wide number management systems.
In a typical company many parts are impacted by new business processes and capabilities required for Serialisation. This requires cross-functional governance and programme teams. Change management is as important as the implementation of technologies.
He highlighted a number of implementation challenges that CMOs will face:
Many Pharma/Biotech companies are very focused on their internal Serialisation implementation and consider that their CMOs are sorting out their own programmes or have already completed for other customers.
There needs to be space on the packing components for serialisation information – for small products this could require packaging redesign
There are a number of design and implementation issues that CMOs will have to consider, and work with their customers to get appropriate decisions made that meet the needs of all parties.
Finally Stephen discussed the key elements of a serialisation strategy and how a CMO could approach developing their strategy, key learnings he has seen from numerous serialisation projects and the need to carefully select appropriate partners to ensure ongoing sustainable solutions.
Packaging Solutions – CMO specific Track and Trace packaging solutions, roll-out experience and learnings
Michel Bullen, Track and Trace Solution Manager, Optel Vision
Michel presented on the challenges a CMO will be faced with when implementation Serialisation. He discussed the impact of the physical pack design, the need to change artwork and the impact on line operations.
He emphasised that limitations the CMO might have on print area size and location need to be discussed with customers to ensure their expectations can be addressed. In aggregation, the limits on case sizes also needs to be discussed.
He showed a series of videos showing different solutions for printing and vision systems on both manual and automated bottle and blister lines.
Pharmaceutical Serialisation – Onboarding your CMO Network
Graham Clark, Director CDMO/3PL Business, TraceLink Inc
Graham presented on the challenges TraceLink see CMOs will have to overcome and the timelines involved. This shows that there will be a resource crush over the next 12 months as implementation deadlines approach.
Both Pharma companies and CMOs need to consider the numbers of partners they have, the timeline to implement at any partner, the impact on down-time and production schedules and the time to change artwork. The sequencing of all of this means that there are only so many partners you can go live with at any one time.
He also discussed the IT integration requirements between PharmaCos and CMOs to share Serialisation information. It is not feasible to do this manually but suitable systems that can integrate to the various systems at partner sites are required.
The Seminar then broke into a number roundtable discussions around implementation challenges, risks and solutions, covering:
- Internal/Site Serialisation programme strategy
- Packaging Line implementations and artwork changes
- Serialisation IT systems: Implementation and Integration
- CMO Serialisation readiness and support strategy
- IT connectivity/integration with CMOs and customers
- ROI/Value beyond compliance with Track and Trace
- Hidden challenges of Serialisation and long term code stability
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