This is the level of service from a ‘leading’ serialization L4/L5 vendor that the pharma industry deems acceptable.
- Manufacturer’s CMO and 3PL integrations are operating as expected. No changes to data/ no changes to configuration are made
- Manufacturer gets a call from their 3PL that data was not sent for a shipment that has just arrived
- Manufacturer starts to investigate and finds that recent serialization data from their CMO is not being communicated to the 3PL. Manufacturer opens support case with L4/L5 vendor
- Manufacturer gets charged thousands of dollars by their 3PL due to not being able to provide serialization data on time
- L4/L5 vendor takes over a week to determine that the root cause was due to a ‘fix’ for a defect they released as part of a previous version upgrade
- Issue was never identified by the L4/L5 vendor because their internal testing doesn’t cover customer specific setup/configuration
- While the issue is being investigated, the manufacturer has to hold batches from release so as to not incur additional late data fees from their 3PL
- L4/L5 vendor informs Manufacturer that the timing to make a ‘fix’ to resolve the issue caused by the earlier ‘fix’ is unknown. Instead L4/L5 vendor directs manufacturer to make changes to their system in order to correct the issue.
- Manufacturer has to log a quality event internally to document the impact to product supply and justify the system changes.
- Manufacturer makes changes and as part of quality procedure must test the changes.
- L4/L5 vendor informs Manufacturer there is no technical way for the Manufacturer to test changes themselves- thus the manufacturer is forced to request testing support from the CMO
- CMO charges manufacturer over a thousand dollars PER TEST (Curiously the L4/L5 vendor of the CMO is the same L4/L5 vendor as the manufacturer)
End result- Manufacturer is out thousands of dollars, hours of internal resource time spent troubleshooting, supporting and authoring quality documentation and experienced a disruption to product flow. All for an issue originally caused by the L4/L5 vendor which was completely avoidable.
With any other vendor
- the manufacturer would have had control over releases- allowing for standard quality activities to be performed that ensure proper qualification within the manufacturer’s specific setup/configuration/deployment.
- the manufacturer would be able to test any-and-all changes themselves, rather than be forced to engage in extremely costly support activities with their partners
Manufacturers desperately need to recognize how unsustainable this ‘status quo’ is going forward as everything ramps up to new levels (e.g. more connections, more complexity, more use cases, more exceptions).
Pharma industry- It doesn’t have to be like this. Demand better. And if things don’t improve- then make changes- as we’ve seen recently the biggest pharma’s recognize the need to make changes- you can do the same.