Saturday, June 12, 2010

Patients Take the Individual, not the Average

Many decades ago, my high school science club sponsored a field trip to Eli Lilly. Our little group of longhaired and bell-bottomed kids (after all it was the 60’s) was ushered into a little room to watch the introductory video about the history of the company and Colonel Lilly. This was followed by a guided window tour by a Lilly employee who would never know that he started a sequence of events in my life that led me to the pharmaceutical industry.

I have often thought about that day, which gave focus and purpose to my academic studies. But these many years later, I mostly remember the tour guide.

I recall how he pointed to each piece of equipment and explained what it did, how it worked, why it was important to the process, and even who was important as he pointed to each operator in the area and told us their roles.

When we finally arrived at the end of the tour, our guide showed us the final product being filled and packaged and said that everything we had seen up to this point was important for each and every vial that was coming off the line. It was with a reverential awe that our guide said that each vial would be going to a person whose life depended upon it.

That tour guide got it right. Patients take the individual, not the average.

It is manifestly impossible to sample a sufficient quantity of finished product to assure the conformity down to the unit level. However, it is the unit level that is taken by the patient, sometimes daily for their entire life.

So, if we cannot provide adequate assurance down to the unit level by testing alone, and if it is important that we must for the sake of each use by the patient—then what gives? Is this a double bind?

The answer is in the Quality Management System.

The purpose of each element of the Quality Management System is to collectively work together to control the manufacture of the drug product from the suppliers’ materials received at the dock to the final product in the shipping containers coming off planes and barges around the world and onto hospital and pharmacy shelves—through to the end of the expiration date.

Each step along the way from dock to stock is based on science and engineering. The Quality Management System ensures that the science and engineering foundation is vigilantly protected from undesirable and unintentional variation that could negatively impact the product at the patient level. And if it does, the problem and product impact are thoroughly investigated and the underlying cause is engineered out.

This is the field of Quality Assurance. It’s all about the patient and the individual unit, as well as the controlling the way we work to ensure consistency and predictability. Patients deserve no less.

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