GMP-Monitoring Systems

One of the essential means of ensuring the quality and safety of pharmaceutical products in accordance with GMP requirements is the monitoring of GMP-critical parameters during the manufacturing process. This includes various physical parameters related to process utilities, the manufacturing process, and the environment.

Initially, the measurement and evaluation of such monitoring parameters were carried out manually by manufacturing facility personnel at set intervals in accordance with established operational procedures. This process required significant human resources and did not provide optimal reliability, as the frequency of measurements could not be high, and there was a considerable risk of human error, both during measurement and in the interpretation of the results.

With advances in technology, automated monitoring systems are increasingly being used. These systems free company staff from routine tasks, eliminate the human factor, and significantly increase the frequency of measurements. The frequency can be high enough for monitoring to be considered continuous, which is gradually becoming a regulatory requirement for more and more systems and processes in the pharmaceutical industry.

The most common GMP monitoring systems are designed for continuous, real-time automatic monitoring and recording of the following environmental parameters in pharmaceutical cleanrooms and storage facilities:

Temperature

Relative Humidity

Static Differential Pressure.

Typically, such automatic monitoring systems are referred to as EMS (Environmental Monitoring System), though other names, such as FMS (Facility Monitoring System) or RMS (Room Monitoring System), may also be encountered. These systems can collect information from sensors installed in process and auxiliary equipment, clean utilities generation/storage/distribution systems (e.g., Purified Water / PW, Water for Injection / WFI, Compressed Air / CA), as well as from airborne particle counters and similar measuring devices.

Alarm/warning signals are automatically generated and sent to responsible personnel if the monitored parameters deviate from preset values for longer than the allowed delay time.

As with any electronic/computerized systems, monitoring systems are also subject to risks associated with hardware and software errors. Many critical errors cannot be detected during simple functional testing of the system. Therefore, it is necessary to perform full-scale computerized systems validation (CSV) for GMP monitoring systems. When purchasing monitoring systems, it is essential to choose reliable suppliers who specialize in GMP/GxP applications and can professionally support the entire GMP/GxP computerized system lifecycle in accordance with GAMP5 guidelines and applicable regulations, such as EU GMP Guideline Annex 11 and FDA 21CFR Part 11.

A unique combination of expertise in pharmaceutical technologies, GMP/GxP, GAMP, validation, and IT/automation enables our company to develop, build, and support reliable electronic monitoring systems that meet the most up-to-date and stringent regulatory requirements. Tarqvara Pharma Technologies OÜ develops and supplies innovative Tarqvara GMP monitoring systems for the pharmaceutical industry, complete with a comprehensive computerized systems validation (CSV) package.