Challenges in serialisation programme and best practices

Naveenkrishna Tarur, Principal Consultant Life Sciences Domain Consulting Group, Infosys, elaborates on the need to establish a credible roadmap for serialisation programme by pharma companies

Nowadays pharma companies are racing against time to meet regulatory deadlines. In this absorbing period of uncertainty, budgetary pressures, availability of numerous solution options, technology advancements and options, many a times, companies tend to jump and take a ‘leap of faith’ which often has been observed to land in rework. Hence, it is very important for pharma companies to establish a credible roadmap for serialisation programme after meticulously considering the nature of challenges and due considerations to some of the best practices thereby ensuring higher rate of success of this initiative.

Challenges faced by pharma companies in serialisation initiative

Understanding serialisation levels and its interpretation: Serialisation initiative for any pharma company must be global in nature, hence, must be perceived and sponsored as a global programme. Any contrary assessment will eventually lead to a lot of rework and budgetary escalations. Commercially available of the shelf serialisation solutions ranges from L0 to L5 Levels. They start from L0 – printer/ scanners to L5 – enabling business partners throughout the supply chain to achieve track and trace capability. But many pharma companies still tend to visualise and restrict serialisation initiative at production line levels. Cost of L4/5 serialisation are equivalent to L0-L3 serialisation solutions for one or two production lines. Thus, by adopting this myopic approach, many companies deprive themselves an opportunity of achieving supply chain excellence through adoption of L4/ L5 solutions, which could have come from a medium level of delta investment.

Keeping abreast with regulations

Regulatory provisions have been quite dynamic with frequent amendments not just in India but elsewhere. Regulatory reporting, procedures, applicability and timelines have become moving target. This is posing tremendous level of uncertainty to project teams, resulting in iterations to already established  serialisation roadmap. To address this challenge, pharma companies have to identify their product and market mix, then start with the segments which are procedurally clearer. Many pharma companies are now targeting to go live first with Russia, followed by the EU. Many companies have to place Brazil plans on hold midway to wait for clearer picture to emerge. Hence, serialisation road map must be flexible and accommodative to such late changes.

Always evolving and complex global pharma supply chains

Today’s pharma supply chains are highly dynamic thanks to dynamic product portfolio, newer compounds making product lifecycles shorter and emerging/ever changing distribution channels, production lines, business partners like 3PLs, CMO, outsourced service providers. For a credible global serialisation capability, pharma companies have to consider all the stakeholders in their supply chain and enable them. They need to be on-boarded right at the programme launch. Survey of partners’ IT landscape and their readiness is a very important exercise, if neglected, may jeopardise L4/L5 track and trace programmes.

Diverse IT landscape and processes due to inorganic growth of pharma companies

Most global pharma companies have taken inorganic route for growth. Resulting mergers and acquisitions have created localised business processes and their IT shop hosts diverse IT solutions. For a credible serialisation programme, establishing seamless integration with all these desperate ERP and MES systems should be viewed as CSF critical success factor. To enable successful track and trace functionality, companies should ensure fairly stable environment for ERP, ECM, and BI.

Synchronising serialisation programme with other IT programme

Serialisation programmes are global in nature, hence care must be taken to give primacy to it and also synch up the milestones with that of other programmes that may be running parallel. Projects having dependencies must be planned well ahead of time. If there are large scale renew/ rework projects that are running in parallel, key focus must be given to alignment of key milestones of serialisation timelines especially of integration and testing with other tracks.

Some of the best practices we recommend to pharma companies

Serialisation programme should be seen as an opportunity to achieve larger organisational goals like supply chain excellence, brand loyalty and not as regulatory entrusted obligatory goal.

Serialisation roadmap should consider global picture of not just regulatory framework, but also multidimensional aspects like – product portfolio, newer markets, additional production location and lines, ongoing and future IT roadmaps for ERP, SCM, DW.

Serialisation roadmap should be pyramidal with strong L0-L3 as base and L4-L5 track and trace capabilities sitting on top as global solution, integrating with ERPs, SCM, partner dystems etc. hence they must be interpreted rightly.

• L0 Serialisation Solutions

1. Printers and vision systems: Serialisation numbers printed and inspected

• L1 Serialisation Solutions

1. Unit level controller and human-machine-interface (HMI) stations: Serialisation and aggregation data management per station

• L2 Serialisation Solutions

1. Line controller: Serialisation and aggregation data management for the entire packaging line

• L3 Serialisation Solutions

1. Site server: Serialisation and aggregation data management for the entire facility

• L4 Solution

1. Business planning and logistics: serialisation interface to enterprise resource planning (ERP) and manufacturing execution system (MES)

• L5 Solution

1. Supply-chain track and trace serialisation data event repository

Chart out regulatory requirements and keep abreast with amendments for each country

Select service providers preferably who provides L0 –L5, who offers private cloud, able to generate and accept externally generated serialisation numbers, and that offers Global L4/L5 template solution. If your pharma supply chain is limited to select geographies and there is no medium-term plans for expansion, then select the solution provider suitable to this profile, otherwise you would be spending unnecessarily.

Establish a strong serialisation organisational structure

For a successful serialisation programme having a strong PMO – organisation structure is very important. It is advisable to set up a Global Serialisation Steering Committee (GSSC), which has direct reports drawn from cross functional global team.

Most importantly, companies should exercise great deal of involvement into this programme than merely reply upon outsourced partner. Hence,  sponsors while establishing organisation structure must identify personalities who can run the show and make it happen.