Environmental Monitoring and Data Integrity
Routine Environmental Monitoring in GMP cleanrooms is a manual process. It can can be complex and typically involves thousands of sample data points per month, manual data transcription and all too frequently technicians have to deal with data gaps and integrity challenges.
Routine Environmental Monitoring programs should be based on a risk assessment of contamination threats to the product during the manufacturing process. The rules for classification do not take this into account i.e. the sampling locations for monitoring may be very different to those used in classifying the room itself and this means that when the risk is identified in the location the product has already been exposed to risk.
The FDA’s ALCOA advice clearly targets manual configuration and data transcription practices.
• Are controls in place to ensure that data is complete?
• Are activities documented at the time of performance?
• Are activities attributable to a specific individual?
• Can only authorized individuals make changes to records?
• Is there a record of changes to data?
• Are records reviewed for accuracy, completeness, and compliance with established standards?
This video clearly shows the stages in this process ..https://www.beckman.com/air-particle-counters/met-one-3400-plus/video-gallery.enjoy!