I’ve been thankful for many things over the years; usually for health, family, employment, and, especially in late November, for roast turkey and dressing, but Stability has somehow escaped the gratitude list until now.
There are some things we’ve taken for granted in our hallowed halls of chambers and laboratories. Our equipment performs amazing feats, whether it be continuous precise operation 24/7/365 or informing us that that a couple parts per million of a degradant has appeared in our product. Laboratory Information Management Systems capture our data, linking it to our equipment, supplies, procedures, and operators and alerting us to OOS’s and ominous trends. They also deliver us from many data integrity pitfalls so common in manual systems. Equipment and service vendors have matured and sharpened over the years to the point where they know and anticipate our needs, offering advanced and proactive products instead of ones we had to adapt in place. Likewise, CRO’s have evolved
in best practices to meet or exceed our expectations. Stability stakeholders also get a place on my thankful list; statisticians and regulatory affairs professionals who transform voluminous numbers into acceptable CMC reports, validation teams that certify our equipment performs what it purports to do, and quality assurance who keeps us sharp in the things of compliance are just a few examples of the dozens of teams that enable us to do what we do. Lastly, the stability operations group, who wrangle protocols, samples, chambers, monitoring systems and reports against a backdrop of target dates, operations windows, and short staffing.
To all those, and for all the technology and knowledge that enable the Stability function in getting a medical product into the hands of a doctor or patient, I gratefully lift my glass of apple cider.