Monitoring storage and production environments typically requires regulatory compliance along with demands for safe and effective monitoring systems that will protect a pharmacy’s livelihood and patient health.
Regulatory bodies including the FDA, EMA, CDSCO, NMPA, MHRA and ANVISA, as well as global institutions and associations like the WHO, ISPE, PIC/S, emphasize the need for accurate measurement, data integrity, and secure recording of critical process parameters (CPP). This requirement exists for pharmaceutical laboratories and manufacturing environments.
FDA 21 CFR Part 11 and EudraLex Annex 11 regulations apply. Recorded data should comply with ALCOA+ principles for data integrity as specified in:
Guidance on how to implement compliant EMS and BMS systems are detailed in:
Traditional facility management systems use a building management system (BMS) to serve GxP and non-GxP areas. However, this method can lead to higher CapEx and significant OpEx.
A GMP compliant EMS performs important data related tasks such as monitoring critical process parameters. This requires qualification and validation activities that are not necessary for the BMS Good engineering practice (GEP) implementation.
ISPE guidance suggests considering the segregation of building management systems and environmental monitoring systems (EMS). Therefore, Eurotherm approaches EMS solutions with segregation in mind to help eliminate unnecessary qualification and validation time and costs in the BMS.
Embracing digitalization and adopting industry best practices, designed to aid compliance to FDA 21 CFR Part 11, EudraLex Annex 1 and Annex 11, and Good Practice guidelines.
Adopt a paperless environmental monitoring solution to:
Digitalize your systems and increase your data utilization to:
Future proof the monitoring of your storage and production environments by:
Adopt a defense-in-depth cybersecurity approach to achieve multiple physical and digital protection layers:
A flexible technology architecture that can deliver:
Such data is provided in a format that can serve manufacturing execution system (MES) platforms and analytics services.
In a QbD approach, product quality is continuously monitored and controlled at the earliest stages.
As defined by the process analytical technology (PAT) approach, Eurotherm on-premise or remote EMS digital engineered solutions can assist in achieving manufacturing efficiencies through data measurement and root cause analysis on CPP deviations. Eurotherm digital engineered solutions (DES) can produce exception reports and time-stamped evidence for the correlation of parameter behaviors at their occurrence.
Eurotherm has developed a wide range of services, designed to meet the quality standards required by the Life Sciences industry.