By Sarah Beale, MasterControl
Documentation is the thorn in the side of life sciences companies. The saying “if it isn’t documented, it didn’t happen” sums up the approach of the U.S. Food and Drug Administration (FDA) during inspections. A look at the data collected by the FDA makes it clear that in life sciences, standard operating procedures (SOPs) tend to be a problem. For fiscal year 2020, the most common inspectional observations for biologics, devices, and drugs involved SOPs.1
For biologics, companies failed to “establish, maintain, and follow manufacturing SOPs.” For devices, a “lack of or inadequate procedures,” specifically as they relate to corrective action/preventive action (CAPA). And with drugs, “procedures not in writing, fully followed,” specifically as they relate to the quality control unit. To avoid a Form 483, life sciences companies need a methodical approach to their SOPs.