Pharma Logistics IQ recently conducted a survey to find the concerns and priorities of those in the later stages of serialization implementation. About 30% of respondents reported that implementing serialization has been a bigger undertaking than they thought, impacting their production cycle more than expected.
Resource allocation: These challenges arise because this is a new process; organizations don’t have the experience to accurately assess the resources needed to implement serialization. As a result, most of the companies surveyed reported that they were behind in optimizing the efficiency of their track and trace programs, with less than a third being completely satisfied with the speed and cost effectiveness of how they resolve issues in this area. Organizations either risk speeding up the implementation process and making it inefficient, or missing the deadline which is quickly approaching.
Supply chain management: Majority of implementation issues and slow-downs occur around the supply chain. In the Pharma Logistics IQ Survey, a third of respondents named “working with suppliers to fine tune serialization capabilities and functionalities” as their main concern for 2017. Many companies operate on a global scale, with many different supply chains to consider that each extend even further.
A major concern for organizations is what happens when supplies and products are out of their immediate hands and data needs to seamlessly travel up and down the supply chain. This is especially the true in the case of a recall, where action needs to be quick and accurate to avoid patients getting sick.
Additional regulations: Since many of these organizations are operating internationally with many different supply chains, they also face the challenge of additional—and sometimes competing—regulations among suppliers. For example:
The FDA’s Product Identifier Requirement. This new requirement was just announced June 30, 2017. Although manufacturers are mandated to begin including product identifiers on prescription drug practices starting in November 2017, this announcement said that the FDA is delaying enforcement of that until November 2018 to provide additional time and avoid supply chain disruptions. Organizations that have to comply with the FDA and other regulatory bodies might now have conflicting priorities when implementing serialization because some bodies will be enforcing it before others.
The EU (European Union) Falsified Medicines Directive. This pan-EU initiative aims to prevent falsified medicines by requiring safety features on outer packaging to prevent and detect tampering. It also introduces an EU-wide logo to identify legal online pharmacies, sets tougher rules for controls and inspections of active ingredients and strengthens documentation requirements for distributors. This is in addition to all other requirements, which puts organizations under even more compliance pressure.
