Regulatory uncertainty and cost are stalling serialisation and traceability implementation
But it could be used to create competitive advantage, survey says
The three biggest challenges to implementing serialisation and traceability systems for the pharmaceutical industry are regulatory uncertainty, equipment capital expenditure and that traceability is a compliance-only issue, a report has revealed.
However, Serialisation & Traceability: Where are you? a survey carried out by PharmTech, a US consultancy based in Libertyville, Illinois, suggests that the pharmaceutical industry should move away from this mindset towards thinking about how to use this new information to improve business and create a competitive advantage.
PharmTech surveyed pharmaceutical professionals to gauge their attitudes to four specific areas surrounding serialisation and traceability – awareness, readiness, business value and challenges to implementation.
Respondents were from pharmaceutical manufacturers (64%), contract manufacturers (18%), distribution/wholesale partners (8%) and other functions (10%). Of those who replied, 72% came from North America, 18% from Europe and 10% from Asia.
In general, the survey found that most companies were aware of the California e-Pedigree and Serialisation Bill and US FDA guidance on standardised numerical identifiers. Acknowledgement of international legislation was mixed. Less than 10% of respondents were unaware of any of the guidelines.
PharmTech said it was surprised at the underestimation of how large a task implementing a serialisation and traceability solution is. Although nearly 60% of respondents expected the timeline to be one year or less, in reality it could take large pharmaceutical manufacturers an average of 3–5 years, depending on the number of lines and products involved.
The view that there is a ‘plug and play’ software/hardware solution was prominent and increasingly optimistic, the report said. Concerns over interoperability of IT systems, inventory build-up due to a line being shutdown for modifications, trading partner integration, data access and handling of queries were not even considered.
Approximately 50% of respondents said they had conducted some form of readiness assessment, however, more than 60% have not begun a pilot.
Respondents had individual perceptions of the value serialisation and traceability could give to their businesses, with the top two being recall management and brand protection. Improving forecasting and planning, distribution processes and inventory control also ranked highly.
To enhance their preparedness for installing a serialisation and traceability system, PharmTech recommends carrying out a Traceability Readiness Analysis (TRA) to identify in advance exactly what systems, people, processes, modifications, budget and timeline may be necessary.
This TRA will enable manufacturers to understand the framework of what needs to be done and prioritise projects that can be tackled now, regardless of future regulations, and what projects will be rolled out as necessary once the regulatory landscape becomes more defined, PharmTech said.
‘Rather than being overwhelmed by the enormous task in front of them, a TRA will provide a road map to a customised traceability solution that provides the business value and return on investment that they expect, while adhering to changing regulatory guidelines.’