I was a judge for a junior high school science fair where young minds applied the scientific method to everything from bean sprouts to producing amino acids from primordial ooze. It was great to see creative minds at work as each explained their hypothesis, methods of observation, data collection and conclusions.
Of course, I took the opportunity to explain to each how their scientific skills would be of tremendous importance in helping sick people get better in the exciting industry of pharmaceutical manufacturing. Yeah—it was a real “sales job,” but I could not have been more serious.
So—what has happened to some people in our industry since they were in the eighth grade?
We work in a science-based industry. Sometimes you have to look hard to find a scientist in the day-to-day operational world of pharmaceutical manufacturing, particularly in the corner office.
Perhaps this explains the difficulty we often face when manufacturing problems occur that could potentially affect a batch of product. Rather than the response being: “Glad you caught that. Now, let’s gather all the data as quickly as possible to investigate the possible product impact,”—it’s “Dang! How in the world are we going to position this one?”
It is particularly disheartening when the role of QA deteriorates from data-driven decisions that provide scientific (and legal) justification, to unsubstantiated opinions. The former is science; the latter is creative writing. All too often QA is put into the creative writing business. The effect of a weakened role of QA has been noted recently in Warning Letters. (See The QA Pharm, 9/25/10.)
CGMPs use the term “justify,” not “rationalize” for a reason. So, let’s review the important difference between them:
Justify v. 1. To demonstrate or prove to be just, right, or valid. 2. To declare free of blame; absolve. 3. Law. To prove to be qualified.
Rationalize v. 1. To make rational. 2. To interpret from a rational standpoint. 3. To devise self-satisfying but incorrect reasons for (one’s behavior).
Your assignment:
1. What is the quintessential difference between “justification” and “rationalization?”
2. Locate in the GMPs where the word, or some form of the word “justify” appears. What is the context, and why is justification important?
3. From a patient’s perspective, which would you expect to be the modus operandi in the pharmaceutical industry: rationalization, or justification?
