An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS) – an EMS monitors the environment of a facility, whereas a BMS controls the environment.
What are the options?
There are many types and manufacturers of both BMS and EMS solutions, each with varying options. For example:
|-||BMS (Good Engineering Practice)||EMS (Good Manufacturing Practice)|
|Control of temperature, humidity and pressure throughout a facility||Monitoring and historical logging of GMP critical environmental parameters including:|
|Control of plant (e.g. boilers, chillers, production or waste water systems)||Monitoring and historical logging of GMP critical equipment including:|
|Provide access control security (e.g. card swipe access) throughout a facility||Alarming of critical environmental and equipment out of specification events|
|Provide CCTV or video surveillance throughout a facility||Strict access control including audit trail, electronic records and electronic signatures in line with FDA 21 CFR Part 11 and PIC/S Annex 11|
Are there different levels of compliance?
One of the main things to note with the installation of a BMS in a GxP environment is that its implementation typically falls under Good Engineering Practice (GEP) and not Good Manufacturing Practice (GMP). This means that the BMS has reduced documentation and validation requirements.
However, the installation of an EMS does fall under GMP, with all the expected validation rigor associated with GxP equipment and systems.
Should they be separate or combined?
As you can see, there is a clear difference between the intent of the two systems. However, a BMS and EMS are commonly combined into one system. A view is often taken along the lines of, “I’m already installing a BMS to control the environment, why can’t it monitor as well?”
However, there are many benefits to having separate systems:
|-||Benefit of separate systems||Details|
|Only EMS is the GMP critical system||The BMS does not necessarily have to be fully validated because the GMP critical data is logged and stored on the EMS. This simplifies validation activities as EMS sensors will only be placed in GMP areas (e.g. laboratories, critical storage, production suites, etc.) whereas the BMS sensors are throughout the facility, including GMP and non-GMP areas (e.g. offices, shared spaces, bathrooms, car parks, etc.).If the systems are not separated, the BMS becomes the GMP system. Obviously you don’t want to waste time validating sensors in a non-GMP area just because they are attached to a GMP system.|
|Change management is only required for GMP impacts||If you wish to adjust a GMP critical set-point, it must be handled under the facility Change Management system. If the BMS is the GMP system, full change request documentation will need to be completed even if, for example, Mary in Accounts wants the temperature turned up a degree.|
|Monitoring data if the BMS stops||If the BMS was to stop, whether from failure or scheduled maintenance, the EMS will continue to run and record regulatory data. So the EMS could show that the product was maintained within the specification even during a BMS outage.This could mean the difference between saving or rejecting a batch.|
|Quality of hardware||Some BMS solutions are configured to use the BMS hardware, software and sensors. Sometimes these sensors are of basic HVAC quality and difficult to calibrate – that is, not what you would want for a critical GMP system.Using higher quality sensors on the EMS can achieve the accuracy and repeatability requirements needed.|
What EMS system should I use?
There are many factors in choosing an EMS solution – but whatever system you choose, the system:
- Must be 21 CFR Part 11 and Annex 11 compliant
- Should be implemented in line with the GAMP5 guidelines.
Below are some different EMS solutions and the benefits and disadvantages of each system:
|Data Loggers||< 20 points|
|Paperless Chart Recorder||< 50 points|
|SCADA + PLC / DSC||> 50 points|