Thursday, June 23, 2022

We can do better than this.....

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. 


Friday, January 7, 2022

What manufacturers face in complying with DSCSA 2023 data exchange requirements

It’s shaping up to be an interesting year for pharma manufacturers in their preparation for 2023 DSCSA compliance.  There are several components of the 2023 milestone that will require manufacturers to carry out serialization projects ahead of the deadline- and many of those projects will need to occur this year (2022) to meet industry expectations.

Central to the 2023 requirements is the need for the data exchanges sent upon the sale of drugs to include serialization data.    To date, these data exchanges (often referred to as T3s) have contained lot-level information only and have been accomplished via a combination of EDI messages (ASNs) and portals.

As highlighted in previous posts, the 2023 milestone represents the time when the pharma industry will need to enable data integration across the entire supply chain.   The approach identified in the US is to establish point-to-point connections between all responsible entities. (e.g.  a manufacturer needs to ensure there is a mechanism to exchange serialization data with each of its downstream customers)          

Many manufacturers, especially virtual manufacturers, may be in for a shock when realizing the level of effort they’ll need to expend to establish these point-to-point connections.   Why is this?

To date, many manufacturers have had the luxury of relying on their 3PL partners to establish and manage data exchanges with downstream customers (e.g. T3 exchange). These services have been provided by many 3PL’s as part of standard serialization support packages.

But, as noted, come 2023 these data exchanges need to transition to serialized exchanges and we are now starting to see some clues as to how 3PLs plan to offer support.  Unfortunately many manufacturers have learned, or will soon learn, that their 3PL will not support exchanging serialized data directly with downstream customers.  In those scenarios, that means the responsibility to establish and maintain connections with all downstream customers falls back on the manufacturers. And because the industry has aligned around the use of EPCIS to facilitate the serialized data exchanges, all of the connections established using EDI for Lot level T3 exchange won’t offset any of the effort that will be needed.  This will result in a significant undertaking considering many manufacturers may have dozens of (or more) customers.

So what are the next steps for manufacturers?

  • Set up time to discuss DSCSA 2023 with your 3PL(s) ASAP.   

A survey of the leading 3PLs in the US reveals the following range of approaches:

    • Some 3PLs are planning to support sending serialized T3s directly to downstream customers AND will make the data available to the manufacturers as well- essentially extending the service they currently provide for Lot Level T3s
    • Some 3PLs will give the manufacturer a choice- they can either send serialization data directly to the downstream customer -OR- they can send the serialization data back to the manufacturer- but they won’t do both.
    • Some 3PLs are not offering the option to send serialization data to downstream customers and will only send the serialization data back to the manufacturers- putting the responsibility fully on the manufacturers to establish the downstream connections. 

Interestingly enough, I can’t blame those 3PLs for distancing themselves from supporting the direct exchanges with customers.   The amount of connectivity that needs to be established over the next 2 yrs is such an exponential increase over what’s been done across the industry to date, the 3PLs recognize that it will result in an exponential increase in issues and problems- and they simply don’t want to have full responsibility for that.   Can’t blame them.

  •  Understand the impacts to your existing serialization vendor contract

Many manufacturers were fortunate that during the initial implementation of their serialization system the vendor did most of the heavy lifting to establish connections to partners and provide quality/validation documentation. What was often overlooked is that many vendor contracts set limits on the number of partners they will connect and/or the contracts define fees for establishing additional connections.   Look for yourself-you may find ‘small print’ that notes the vendor included the first 1 or 2 or 3 connections, but after that the ‘heavy lifting’ becomes the manufacturers responsibility. 

Again, many manufacturers may be in for a shock when they are presented with increases to their annual recurring fees (to cover the additional connections) as well as new SOWs to provide resource support to establish the new connections. (since many won’t have planned to have the internal resources to do the ‘heavy lifting’ themselves) 

  • Identify the level of effort needed to ensure 2023 compliance and look for ways to minimize the impact to your resources 

Regardless of how your 3PL plans to support serialized data exchanges, manufacturers should recognize some level of resource impact will always fall back on them.  The scope of impact, of course, depends on the 3PL’s plans as well as the level of support provided (or you choose to have provided) by your serialization vendor.    If your 3PL and serialization vendor take on most of the work, then your internal resource impact may be limited to typical document reviews and ensuring validation alignment.  However, the manufacturer will always be on the hook to perform a level of testing to ensure each of the individual connections is working as expected. 

Alternatively, if your 3PL does not plan to support direct exchanges with downstream customers and/or your serialization vendor won’t do most of the ‘heavy lifting’ (or wants to charge you too much) then there is a considerably greater impact on your internal resources.  In this scenario manufacturers will need to oversee the projects to establish connections with each of your downstream customers (even with your vendor involvement).  And while these projects will have synergies in terms of their structure and approach, at a technical level, configuration and testing steps will have to be done individually for each customer. 

Thus a common theme is the need for manufacturers to execute testing in support of establishing these downstream connections.  And the level of testing required (regardless of the scenarios noted above) should not be underestimated.  

  • Consider a minimal need to generate multiple test batches to verify each individual customer connection- and that assumes testing for each connection is successful first time ( 😊 )  
  • Additional test batches will be needed to re-test any failures as well as test any required exception scenarios. (exception handling will be the single greatest cause of headaches over the next 2 years-  the ability to cover a broad range of business scenarios and production-like volumes is the only way to uncover these exceptions)   
  • So a manufacturer who has just 10 customers is looking at 20-30+ simulated test batches, each (likely) incorporating varying products, packaging configurations and all requiring unique test serial numbers. (The more realistic # of test batches needed by most manufacturers is certainly much higher)
  • The options for manufacturers to facilitate all of this testing is limited. 
    • You can ask your CMOs to simulate test batches and some may agree- but the timeliness, flexibility and scalability is out of our control
    • You potentially can leverage your serialization vendor’s UI to simulate batches on a small scale- but this quickly becomes laborious when numerous aggregations and any level of realistic product volumes are required.  Even on a small scale, depending on all set ups required, it may take an hour+ to execute a single test.
The better option is to leverage a simple automated testing tool purpose-built for pharmaceutical serialization projects.   Watch the following brief demonstration on how the Jennason Serialization Test Tool (https://www.jennason.com/solutions) can reduce your testing time to a matter of seconds and give you full control to cover any testing scenario and volume levels required.   In addition to saving you time and money, the tool also generates barcode reports (1D and 2D barcodes corresponding to your simulated serialized shipments) that can be shared directly with your 3PL and downstream customers to better support their testing efforts.  In short, everyone wins.

Commercial details (https://www.jennason.com/shop) are shared during the demonstration as well as options for leveraging the solution as a service combined with Jennason’s advisory consulting. 



 

 

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