All signs point to serialization again taking center stage in pharma in 2018.
While the U.S. FDA offered the industry a yearlong sedative by delaying enforcement of the first phase of the Drug Supply Chain and Security Act (DSCSA) until next November, conventional wisdom is that it was a one-and-done move by the agency.
That means the clock is ticking for many companies that will need to ramp up quickly in the new year to avoid heavy penalties.
At the recent Healthcare Packaging Expo in Las Vegas, companies demonstrating everything from conveyors to labeling equipment included flexible solutions for meeting the coming serialization standards.
While serialization appears to be taking the top spot among 2018 concerns, a series of other trends are continuing to develop and may become more prevalent going forward, including moves in the U.S., Europe, and elsewhere to drive drug prices down, calls for more rapid approvals of generic drugs and biosimilars, vastly improved data collection, analysis, and connectivity across the supply chain, increased use of automation, an explosion of new technologies, and, ultimately, the ongoing commitment to deliver better patient outcomes.
In addition to 2018 trends, this issue of Pharmaceutical Processing delves into tech transfer issues, the unique challenges with process scale-up in generics, special door designs that keep out contaminants, and a cover feature on UPM Pharmaceuticals by our former editor, Meg LaTorre-Snyder.
On a personal note I’d like to thank Meg for her excellent work guiding our editorial coverage over the past few years. While Meg will be missed, I’m delighted to succeed her in the role and pledge to continue breaking new ground in our industry coverage. I look forward to hearing your thoughts as we head into 2018.
Have a safe and wonderful holiday season and a happy and prosperous year ahead!
