Trend Analysis of Total and Viable Particle Monitoring Data and Definition of Alert and Action Limits

Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess overall environmental control performance.

Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. It’s possible to use the limits reported in FDA guidelines or Annex 1 of Eudralex – Volume 4 when the facility is new and/or there is not available data. When there is statistically significant data, it’s essential to establish the proper alert and action limits.

Author

Anna Campanella, PhD Global Pharma GMP Advisor Anna Campanella has experience in pharmaceutical microbiology and sterility assurance. Her experience in the pharmaceutical field started in 2007 as a Chemical and Microbiological Analyst and then as Quality Control Supervisor in a biotech company that produces cell therapy products.

Today, Anna is the Global Pharma GMP Advisor for Particle Measuring Systems. In this role, she collaborates and consults with pharmaceutical companies to develop and implement science-based strategies, and principles to monitor, control and improve the chemical, physical, and microbiological state of various production processes.

 

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