GMP-Monitoring Systems

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

Initially, the measurement and evaluation of such monitoring parameters were carried out by manufacturing facility personnel manually at certain intervals in accordance with established operational procedures. The performance of this work required significant human resources, and, at the same time, did not provide sufficient reliability, since the frequency of measurements could not be held high, and there was a significant risk of human error, both at the measurement stage and at the stage of interpreting the results obtained.

With the development of technology, automated monitoring systems are increasingly being used. They allow you to keep company staff free from the most primitive routine work, eliminate the human factor and greatly increase the frequency of measurements. The frequency of measurements 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 called EMS (Environmental Monitoring System), although other names can be also met, such as FMS (Facility Monitoring System), or RMS (Room Monitoring System). Such systems can also acquire 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, etc.), as well as from air-borne particle counters and similar measuring devices.

Alarm/warning signals are automatically generated and delivered to responsible personnel, if controlled parameters are outside preset values for longer than the preset 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 identified during a simple functional test of the system. Therefore, for GMP monitoring systems, it is necessary to carry out a full-scale computerized systems validation (CSV). When purchasing monitoring systems, reliable suppliers should be chosen 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 experience in pharmaceutical technologies, GMP/GxP, GAMP, validation and IT/automation allows 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 with a complete computerized systems validation (CSV) package.