The topic of packaging and labeling is nothing new and is an integral part of the clinical supply manager’s role. For one reason or another, it is often part of a critical path to meet the necessary First Patient In (FPI ) date. This article will explore some key lessons learned from my own experience of managing multiple campaigns where the clinical supply chain department size is made up one clinical supply manager; call it a one man army (or woman in my case). There are some key factors to bear in mind when managing this resource-limited ‘army’ has to manage the whole clinical supply chain.

  1. Heads UP and Follow UP: It is very important to keep your project manager informed, providing them with a heads up whenever possible to inform them of upcoming tasks. This greatly helps in the planning on their end. Follow up is just as important to bear in mind and whilst being overbearing is not necessary, gentle reminders can be useful in ensuring tasks are completed and information is provided to you in a timely manner. However; remember that you won’t be the only person requesting information, and they will have many similar requests to expedite.
  2. Meetings: As alluded to above, communication is key. it is a necessity to have regular TCs to ensure aligned goals and updated deadlines clearly understood and are on track.
  3. Timeline: Ensure that there are timelines set up for each job and keep each timeline near you. During weekly meetings, go through each line item of your timeline and continue to evaluate where time could be saved. If negotiation is required, days allowed to review documents are often items with good padding that can be trimmed.
  4. Raw components: Many raw components such as bottles, caps, blister cards etc have long expiry periods. Use this to your advantage and order these relatively low expense items ahead of time and in large quantities. Often these sorts of items have long lead times so effective preparation here can be very beneficial.
  5. Project Manager at the CMO: In the real estate world, it is often said the three most important considerations are ‘Location, Location, Location’. In the supply chain world, for packaging and labeling of your supplies this needs to change to ‘Project Manager, Project Manager, Project Manager’. Understanding how your PM and their company works and a strong, cohesive relationship with the PM is essential to successful delivery of your CTM
  6. Drug product delivery: If this is behind schedule (as can be the case), don’t let this halt all operations. There are many tasks that don’t necessarily need drug product on site. For example, pre-production documents can be reviewed and approved ahead of time, as well as label could be printed if needed even at risk to save time.
  7. ID test of Labeled Kit: Firstly, determine if this is really needed. For example, if it is an open label study, or if the bottles are ink jetted, ID test could be waived. Though final decision should be made with the consent of QA . You can ask the ID samples to be pulled at the start of the operation, sent out for testing.and have the results back in time for QA release, so this does not add to the timeline. It is standard practice to send ID samples to the drug product CMO. If your packaging/labeling CMO has analytical labs and the capability to do the required ID test for your product, 5-7 days can be shaved off your timelines if testing is done in house by the same CMO.
  8. Batch record review: The standard time for this is five days for the CMO QA and 5 days for Client QA to review and approve, allowing time for back and forth clarifications. To save time in this process ask for parallel review or even consider having your QA on site. This allows faster response to questions/comments raised by sponsor QA.
  9. Kit list upload in IVRS : QA release is not the last step to have IP available for distribution. IP release in IVRS can sometimes be forgotten and realized at the time of shipment request. The kit list upload file can be prepared at the time you receive EBR and can be reviewed and ready for release by IVRS team as soon as the batch is released by QA

To conclude, the above consideration may not be groundbreaking for all but rather a refresher on strategic planning of your packaging and labeling campaigns which I hope you will find of use. Challenges of supply chain are always new and that is what keeps it interesting!