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.

Statistical methods are intended to improve the quality of decision making. The methods may be used in an ongoing program to analyze collected data. Timely evaluation of data allows the prompt detection of undesired process variation, which facilitates process understanding and may mitigate response variability. The case study discussed in this paper involves the use of trend analysis to analyze microbiological and total particle monitoring data and statistical analysis to define alert and action limits for grade A, B, C and D. The following paragraphs describe the methods of analysis used for this study…

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