Microbiological Trending of Environmental Monitoring Data

Microbiological trending of environmental monitoring data serves multiple purposes:

  • Trending helps to define and hone your limits
  • Trending helps to determine if control of your processes has been lost (or is heading that way)
  • Trending helps to identify the effectiveness CAPA and process ‘improvements’

In order to produce relevant trends, you need to have defined what your alert and action levels are and how many times in a row an alert constitutes an action. You also need to define how many below alert results may indicate an adverse trend. Basically you want to get what is heading out of control under control.

Data to trend includes all data collected from your viable environmental monitoring program.  Showing these trends in graphs allows for easy identification of trends.  As part of your trending, you should identify your top 10 microbe species detected within your production facility.

You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.

Your internal processes and documents will be dependent on which regulatory bodies have oversight at your facility.

A more detailed, though old post regarding trending can be read here.

Some resources:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm124900.htm

http://www.microbiologyforum.org/content/file/PMFNews.17.03.1103.pdf

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/midwest/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4

Approaches to trend analysis of micro monitoring during aseptic processing?

The Question posed on LinkedIn.

“Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC/S GMP Guide for aseptic operations.

As you all know, microbial counts do not follow a normal Gaussian but a logarithmic distribution, such that the classical way of calculating and defining thresholds for alert (often +/- 2s) and action (+/- 3s) cannot be applied.

Hence, what alternative approaches to setting alert and action limits for microbio monitoring data (environment, staff, water, …) do you apply?”

My advice:

You need to have defined what your alert and action levels are and how many times in a row a site can be in alert before this constitutes an action. You also need to define how many below alert results may indicate an adverse trend.

Basically you want to get what is heading out of control under control.

You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.

Your internal process and documents will be dependant on which regulatory bodies have oversight at your facility.

The FDA, PDA, PIC(S), ICH and good resources like the PMF are valuable when developing your internal processes.

Some resources:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm124900.htm

http://www.microbiologyforum.org/content/file/PMFNews.17.03.1103.pdf

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/midwest/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4

The Importance of Trending

What is Trending?

Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading