Sponsor Document Production Has Become Essential

FDA investigators are cracking down on sponsors that are not able to produce documents during inspections, an expert says.

“In the past, … if you didn’t have [a] document, you got an observation on the 483 form, and you had an opportunity to then go back and look and resolve it,” Elizabeth Troll, a quality management specialist said at a recent FDAnews webinar. “Now I think that the opportunity to get a second chance is much more limited, because they have been very clear in their expectations.”

As the agency now asks for more than compliance records, Troll emphasizes the need to archive documents relating to competency-based training.
Drug GMP Report