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An operational pathway to define, design, install, qualify and manage integrated GMP Environmental Monitoring Systems covering particles, microbiology, environmental parameters, software and data.
Continuous and periodic particle monitoring, particle counters, isokinetic probes and sampling locations.
Active and passive microbiological monitoring, surfaces and automated or rapid technologies.
Temperature, humidity, differential pressure and other critical environmental parameters.
Data acquisition, alarms, trending, reporting, audit trails, data integrity and integrations.
Identify the activities, decisions and evidence required at each stage of your Environmental Monitoring project.
Define intended use, URS, risks, system boundary and monitoring strategy.
Design architecture, sampling locations, technologies, software, alarms and interfaces.
Install probes, instruments, tubing, vacuum, network, power and infrastructure.
Execute FAT/SAT, IQ/OQ/PQ, CSV, alarm testing and requirements traceability.
Manage trending, change control, maintenance, calibration, periodic review and retrofit.
Prepare the RFP, compare suppliers and assess TCO, service, documentation and lifecycle.
The Project Library connects each project stage with relevant GuideGxP content and updates automatically as new articles are published.
Define what the system must do, why it is required and how the monitoring strategy should be justified.
Compare architectures and technologies to build a solution proportionate to process and risk.
Turn the design into a representative, accessible, maintainable and qualifiable installation.
Govern software, data and qualification of the EMS as an integrated GxP system.
Keep the system in a state of control throughout its lifecycle.
Build the RFP, vendor assessment, budget and Total Cost of Ownership.
Go deeper into the complete Environmental Monitoring System lifecycle: requirements, risk assessment, architecture, installation, software, qualification and lifecycle management, with editable operational project tools.
The Environmental Monitoring System should be designed in the context of the Contamination Control Strategy, cleanroom qualification, equipment qualification and data governance.
Contamination Control Strategy, cleanroom monitoring, viable and non-viable monitoring.
Classification, monitoring strategy, cleanroom testing and control of classified environments.
URS, DQ, FAT/SAT, IQ/OQ/PQ, change control and lifecycle qualification.
Computerised systems, electronic records, access control, audit trails and data integrity.
Describe the system, project stage and support required. GuideGxP will review the request and, where appropriate, may connect you with a specialist matched to the technical scope and geography.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
