Deviation Torture; Part 1

Deviation Torture; Part 1

January and August were busy months when I worked in a large pharma company as a technical lead in cold chain. Those were the most likely times that shipments of temperature sensitive goods would experience thermal excursions. Short of taking long vacations during those times, there seemed to be no way to avoid what I called deviation torture.

By deviation torture, I mean repeated meetings with molecule stewards and time in the lab to try and replicate in the lab the thermal effects reported from the field. Then assay the product and assess the risk. Finally, have the quality folks sign off.

Then…repeat – repeat – repeat.

Many times, when the exposure was short and shallow, the product showed no evidence of degradation. Other times the product had to be replaced. The time from discovery of the incident to resolution was much too long. Thankfully, when the instances occurred with commercial products, we were only replenishing stock so there was no direct impact of supply to the patients. That was not the case with more scarce clinical trial materials that contained study-specific packaging.

Deviation torture can be avoided by some well-designed foundational studies. These studies establish the thermal conditions outside of the long-term storage conditions that will impact product quality. These studies have two or three steps. I will cover them in Deviation Torture Part 2.