Why is Environmental Monitoring important?
Environmental Monitoring is one of the tools pharma companies must use to obtain knowledge of the state of the Contamination Control in manufacturing cleanrooms.
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)
All three systems should be analysed together to provide reliable information on the state of Contamination Control of the installations and process.
Environmental Monitoring is not meant to be used as a tool to declare the sterility of a manufactured product as it provides limited information. However, also according to the GMP Annex 1 draft:
Environmental Monitoring should be used for routine batch certification, as well as for periodic assessment during process review and investigations.
According to GMP Chapter 2 (2.9) Environmental Monitoring is part of the shared responsibilities between the Head of Quality Control, the Head of Production, and if available, the Head of Quality Assurance.
When talking about the viable particles in Environmental and Personnel Monitoring, the following methods are normally used: settle plates, volumetric air sampling, contact plates, and swabs. 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.
On the contrary, Environmental Monitoring programs are very useful to understand the evolution of the different contaminations over time. For example, trending will allow understanding if changes in the cleaning and disinfection program are being effective or ineffective, whether changes in personnel or training have an impact, or if specific seasonal changes are affecting the type of flora typically encountered. Trending of Environmental Monitoring will quickly highlight changes and potential contamination threats.
A proper Environmental Monitoring program, based on reliable data, will alert the company as soon as trends change, allowing for a proper and quick investigation and obtaining a good understanding of the reasons for the change. Therefore, achieving a level of control of the installations and processes and making possible a safe manufacturing activity.
In the case of sterile pharmaceutical compounding, North-American 503B manufacturing sites must comply with USP 797, while European must follow GMP Annex 1. If their batch size is small, or in case of short shelf life, they may not be able to spend product or wait for Sterility Testing results (14 days). Their quality then must rely on the Environmental Monitoring results which should ensure that their product is sterile.
By reducing the risk associated with a good and effective Environmental Monitoring program you will:
- Strengthen your regulatory position
- Improve product quality
- Assure patient/ / consumer safety
Environmental Monitoring plays a significant role in achieving this goal providing critical information about the manufacturing environment to ensure that the release of a potentially contaminated product does not occur.