We attended the 7th Annual Pharma Packaging and Labeling USA 2015 conference in Philadelphia a couple of weeks ago and thought you might be interested in a few of the key messages that we took away from it.
The event essentially covered three topics – product serialization, labeling & artwork management and product adherence. Presentations and panel discussions included representatives from a number of pharma and biotech companies, including Abbvie, Amgen, Bayer, BMS, GSK, Insmed, Novartis Pharma, Sandoz, Sanofi, Shire, and Takeda.
Some of the key messages from the serialization portion of the agenda and subsequent discussions included:
- One topic that came up several times is the need to actively manage the understanding of the dynamic legislation environment and manage how the many subprojects that typically form a serialisation program are going to respond.
- There appears to be a lack of capacity in the supplier marketplace to serialise the number of packaging lines that support Europe. One study stated it at between 7,000 and 8,000 lines. Supply capacity was stated by one Pharma Company representative to be around 1,000 lines per year. Therefore, companies should be planning ahead and avoiding the late rush that is almost certainly going to happen in the 2017/18 timeframe.
- We had various conversations with pharma and biotech company representatives on the state of the supply base for serialisation line and enterprise systems. It was very evident that the practical experience of these customers is that the solutions, in general, are not as mature as they would hope them to be. Leading to compromise in day 1 solutions, phased delivery of the full requirement, project delays and cost overruns. Implementation plans therefore need to be cognoscente of this.
On the labelling side of things, labelling text content management seems to be gaining some traction. One supplier discussed work they were doing with a Pharma company to pilot a process and system that would manage the content of regulatory labelling data down to the section level of datasheets and regulatory submissions.
Again, in the regulatory labelling space, another Pharma company discussed its work to align core and local datasheet label text. Their conclusions focused on the levels of effort and time this process takes and the need to take a risk-based approach to enable a manageable scope to be tackled.
Finally, there was a very interesting presentation on a study that the HCPC in the US facilitated that looked at the benefits of bottles and various types of blister packaging on the physical stability of products. The conclusions of this study clearly pointed to the use of blisters with a barrier foil providing a superior protection of the product compared to solutions such as bottles. Whilst blisters are the majority format in Europe, in the US they remain a minority primary pack format for solid oral dose products.
If you have any questions about this or would like any contacts for the above topics, please don’t hesitate to contact me at Stephen.firstname.lastname@example.org.