This is a pretty big category, encompassing citations such as lack of or inadequate procedures for:
• Process validation
• Process control
• Environmental monitoring
• Preventing drug contamination
• Sanitation and maintenance
• Regular calibration of mechanical equipment
Looking at this list, it’s not entirely surprising that the FDA recalls thousands of drugs and medical devices every year. Getting your processes in order takes some work, but leveraging the QMS can make it easier. The steps you take now to ensure tighter process control will set you up for success across a range of outcomes, from preventing public safety issues to reducing waste to increasing profits.
