Because patient safety matters, the manufacture of pharmaceutical products is performed under strictly controlled conditions. Microbial monitoring is an important part of GMP regulatory compliance, used to prove that the manufacturing process is under control, especially in aseptic production. The risk-based implementation of sampling plans, as well as the subsequent trend analysis of monitoring results, helps to detect deviations from qualified status, prepare root cause analysis, and follow up with appropriate corrective action and preventive action (CAPA).
According to the draft of the GMP Annex 1 2020 version, the Environmental Monitoring program must be part of the Contamination Control Strategy (CCS) and is typically comprised of:
- Non-viable particles Environmental Monitoring.
- Viable particles Environmental and Personnel Monitoring.
- Aseptic Process Simulation (for aseptically manufactured products only).
When talking about the viable particles in Environmental Monitoring, the following methods are normally used:
- Settle plates.
- Volumetric air sampling.
- Contact plates.
Due to the nature of the sampling methods, even after having designed a very robust program, using a risk-based approach to define sampling locations, frequencies, sampling methods, etc., the information provided by the program will be limited and it will not be very valuable if used as a snapshot of the contamination in the area at a specific moment.
The advantages of environmental monitoring lie in its ability to improve the quality of life for society by highlighting the relationship between the environment and health. Transforming environmental monitoring data into information and communicating actionable insights to the community in a timely manner is crucial for keeping citizens informed of the state of their environment.