BMS, EMS & GMP in pharmaceutical production

How monitoring technology ensures pharmaceutical compliance, safety and quality

Good Manufacturing Practice (GMP) is a key aspect of every pharmaceutical production operation. Correctly applied, it ensures the quality, safety and efficiency of each stage of the process, as well as providing reassurance that the efficacy of the products being manufactured is being maintained in accordance with the required standards.

In turn, GMP procedures depend for their effectiveness on the performance and reliability of Building Management Systems (BMS) and the data integrity of the Environmental Monitoring Systems (EMS).

Although both types of system are computer controlled, their functions are completely different. A BMS monitors and controls the equipment required to regulate the conditions within a production space, cleanroom or storage facility. Control criteria typically include heating, ventilating and air conditioning units, power supplies, fire alarms and security installations.

By comparison, an EMS is designed to monitor the environmental conditions within the same production space and which are considered critical for the manufacturing operation and the quality of the finished product. Monitored parameters normally include particle concentrations, temperature, humidity and pressures, plus the operational status of devices such as fridges, freezers, incubators and water purification units. In each case, the EMS should also provide redundant data logging capabilities, with appropriate communication and networking options for connection to higher-level process and facility control systems.

Designing for GAMP5

EMS systems should be designed to meet GAMP5 criteria. GAMP5 stands for Good Automated Manufacturing Practice. It is intended to help the manufacturers and suppliers of monitoring systems used in the pharmaceutical sector to develop computerized solutions, which can subsequently be validated using a life-cycle model based on good engineering practice and risk management.

The GAMP5 life-cycle model has four stages for computerized or automated systems: concept, project development, system operation and eventual retirement. At each stage, risk management is applied to identify possible issues and establish appropriate procedures to eliminate or reduce them to acceptable levels. This can, for example, be adapted at an operational level to determine the Critical Process Parameters (CCPs), such as temperature, relative humidity and pressure, which have to monitored accurately, reliably and consistently by any EMS system.

Stable manufacturing conditions

One of the key requirements of GMP is the establishment of a stable manufacturing environment. With BMS and EMS systems it becomes possible to ensure that factors such as temperature, humidity and pressure are correctly maintained. Just as importantly for regulatory compliance a GAMP5 system will also ensure that EMS data is captured and analysed in real time to provide full traceability.

BMS and EMS systems can also be used to reduce energy consumption and costs, by optimizing the performance of the building's mechanical and electrical systems, as well as the operation of process and production equipment. Additionally, by maintaining a stable and carefully regulated production environment, it is easier to protect the health and safety of employees.

The Rotronic Real-time Monitoring System (RMS): the modular, integrated EMS solution

Thanks to the latest automation technology it is now far simpler for pharmaceutical manufacturers to implement reliable and high-performance EMS solutions that provide much greater peace of mind.

For example, our industry-leading Rotronic Real-time Monitoring System (RMS) is a purpose-designed automatic environmental monitoring solution for use in all pharmaceutical production facilities. Designed based upon the GAMP5 recommendations, it can be used to monitor from just a few to many hundreds of measuring points. Each device used for monitoring, such as temperature, humidity or differential pressure sensors and data-loggers, can be hard-wired or wirelessly connected to an on-site server or a secure cloud-based platform. In each case, the RMS software allows the user to review, document and visualize all the relevant readings in one centralized system, which is capable of generating alarms automatically if operating thresholds are exceeded, and of creating a detailed audit trail.

Each user can access the system remotely from a computer, tablet or smartphone, with the option to customize dashboards that reflect the specific operational and regulatory requirements of each laboratory.

The system is modular, scalable and extremely flexible. A wide range of hardware options are available, including probes, data loggers, I/O and digital interface modules. Existing proprietary hardware is easy to add, while setup, training and use is quick and simple.

To learn more about our modular real-time environmental monitoring system (RMS):

Related Information

Environmental monitoring is critical to GMP processes
Rotronic Monitoring System Overview

Related Categories

Application for RMS: BMS and EMS