Looked one way, the recent Intas Warning Letter is another example of a foreign company that should not be in the business of manufacturing pharmaceuticals. And that is probably true.

However, even the most egregious document can have some nuggets of wisdom for more mature quality organizations. Take this observation:

An analyst destroyed CGMP records by pouring acetic acid in a trash bin containing analytical balance slips for testing the standardization of (b)(4). A QC employee stated he observed the same analyst destroy KF titration curves and balance printouts. The employee reported the incident to QC laboratory management on November 22, 2022. An investigation into the destruction of the torn CGMP documents and the impact to your drug product quality was not initiated until November 28, 2022.

I sincerely hope you don’t have anyone pouring acid in a trashbin, or putting original data in a trashbin, or pouring acid on original data in the waste bin. But often we focus on the huge issues, shrug and say “That doesn’t happen here.” And hopefully you are right.

It is the last sentence that actually drew my attention. Because this gets to a problem we see in many organizations, some of them rather mature – timely creation and investigation of an event.

Managing Events Systematically

Also it is a telling example of poor inspection conduct. Don’t drag your heels with the inspector is clearly right. Act and act fast.