Eclipse of the Heart Flow Chart
I attended a conference today for pharmaceutical industry professionals and they were discussing following data trends to minimize “out of spec” analytical test results. For those of you who don’t know much about manufacturing, the quality control department is responsible for conducting analytical testing to ensure product safety and uniformity before it is released for distribution. There are upper and lower specification limits that the data must fall within in order to be approved. Any time results are obtained outside of these limits they are deemed out of specification, or OOS. The FDA requires pharmaceutical companies to launch investigations for such atypical results.
The presenters today talked about ways to minimize OOS results. While there are bound to be inconsistencies at some point, the talks today focused on improving statistical methods for interpreting data. Analysts should not focus on one particular instance where the data is out of spec, but rather use the cumulative sum in order to chart the data and observe trends more clearly. This will allow operators to catch data that is headed outside the acceptable range and perhaps troubleshoot problems that may potentially occur, saving the company time and money in lost product batches or OOS investigations.
Anyway, one of the presenters was explaining how tracking the product from the time sampling occurs until the quality department releases the batch for distribution can help you better understand your process and pinpoint trouble spots. He shared a graphic to illustrate his point and add a little vigor to the presentation that I found to be rather amusing, especially in the lull that occurs right after eating a buffet lunch… It’s a flow chart of the 80’s song, “Total Eclipse of the Heart”. I’ve posted it here for your own nerdy viewing pleasure. 😉
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Tags: analytical testing, drug products, FDA, OOS, out of spec, pharma, pharmaceuticals, quality, quality control, regulations, Science, statistical trends