Environmental monitoring (EM) of a GMP facility may be conducted for a variety of reasons. The major reasons for conducting EM are to assess the effectiveness of the cleaning program and to assess the impact of the environment on product quality.
If you were to assess your routine GMP environmental monitoring program, you could use the following criteria.
Criteria 1: Monitoring to assess the effectiveness of the cleaning program. This requires monitoring after cleaning and before processing (at rest). It is typically surface monitoring only. Surfaces should not include product contact surfaces.
Criteria 2: Monitoring to see what is in the environment during product exposure (what the product sees). This involves air sampling and settle plates during processing operations when product is exposed.
Criteria 3: Monitoring to see what contamination may have been introduced during processing. This involves surface sampling with contact plates after completion of processing and includes personnel monitoring.
So, an effective and rational program would clearly state what it was trying to achieve (or which of the above criteria were being addressed).
The various cGMPs require us to monitor locations based on risk. An extension to this is to monitor where useful information (that relates to potential impact on product quality or cleanliness levels or would assist in making a decision about product quality) is obtained.
Monitoring locations can therefore be assessed based on a combination of what you are trying to assess and the value of the data from the assessment.
What is the value of floor monitoring data when you are looking at environmental impact on exposed product that is 1 metre vertically above the floor?
You could use a scoring system to assess the value of the data. On a scale of 1 to 3, one being no value, 3 being very valuable, then the above example would rate 1, and if you had a choice, you wouldn’t monitor that location.
Contact us for support to design and implement an effective and compliant GMP environmental monitoring program for your facility.
This post comes from our October 2015 Journal. You may also be interested in these posts: