Good Manufacturing Practice (GMP) is the quality framework ensuring that medicinal and other regulated products are consistently produced and controlled to the standards appropriate to their intended use, including environmental monitoring of production and storage areas.
Good Manufacturing Practice (GMP) is the quality framework that ensures medicinal products, APIs and other regulated goods are consistently produced and controlled to the standards appropriate to their intended use. Environmental monitoring of production, cleanroom and storage areas — temperature, humidity and pressure — is a core GMP control.
GMP places heavy emphasis on data integrity (often summarised as ALCOA+: data must be Attributable, Legible, Contemporaneous, Original and Accurate), calibrated measurement, controlled access, and documented response to deviations. Seemoto supports each of these with continuous environmental monitoring, factory-calibrated sensors, role-based access control and a tamper-evident audit trail.
What GMP requires
Environmental monitoring
Production, storage and cleanroom areas must be monitored for the conditions that affect product quality (temperature, humidity, pressure).
Data integrity
Records must meet ALCOA+ principles — attributable, contemporaneous, original, tamper-evident and accurate.
Calibrated measurement
Measurement devices must be calibrated with documented, traceable accuracy.
Controlled access
Access to monitoring systems and records must be controlled and attributable to individual users.
Deviation documentation
Deviations require documented detection, investigation and corrective/preventive action.
How Seemoto supports GMP
Continuous environmental monitoring
Wireless temperature, humidity and pressure monitoring across production, storage and cleanroom areas with configurable thresholds per location.
Factory-calibrated, accurate sensors
Sensors are factory calibrated per device with ±0.5 °C accuracy and individual calibration certificates available on demand.
Role-based access control
User permissions restrict who can view, configure and export records, and every action is recorded in the audit trail.
Tamper-evident records
Measurements are time-stamped at capture and stored in a tamper-evident cloud with 5-year retention, supporting ALCOA+ data integrity.
Deviation handling tools
Excursions trigger real-time alerts and structured deviation records with corrective-action fields for your quality system.
What's included vs. what's a service
Transparency matters in regulated buying. Here is exactly what comes with a standard Seemoto monitoring subscription, and what is delivered as a separately scoped professional service.
Included by default
- Continuous environmental data logging
- Role-based user access control and audit log
- Deviation alerts and handling tools
- Standard compliance reports
- 5-year encrypted cloud retention
- Per-device factory calibration certificate
Professional services (scoped separately)
- IQ/OQ/PQ validation documentation
- Temperature mapping / qualification studies
- Periodic recalibration beyond factory calibration
- Signed compliance report packages
Where GMP applies
Primary sectors: Pharma manufacturing · Biotech & cell/gene therapy · Medical device production · Cleanrooms
Frequently asked questions
Readings are captured automatically and time-stamped at the moment of measurement (contemporaneous and original), attributed through role-based user accounts, stored tamper-evidently, and remain legible and exportable for the full retention period. This directly supports the ALCOA+ principles GMP inspectors apply.
Every device is factory calibrated before delivery with an individual, digitally accessible calibration certificate and ±0.5 °C accuracy. Periodic recalibration is available as a professional service that produces an updated device-specific certificate.
Validation (IQ/OQ/PQ) is a separate, scoped professional service — it is not bundled into the standard subscription. Seemoto delivers a Validation Master Plan, IQ/OQ/PQ protocols and reports, and risk assessments when validation is engaged.
Yes. Role-based permissions let you control who can view dashboards, change thresholds, acknowledge alarms and export records. All access and configuration events are recorded in the audit trail for accountability.
GMP guides & resources
Practical, vendor-neutral guides related to GMP compliance and temperature monitoring.
Temperature Mapping: A Practical Guide for Warehouses, Cold Rooms & Vehicles
What temperature mapping is, when it's required, how many sensors you need, how long to run a study, and what a compliant mapping report must contain.
Read guide →GDP Warehouse Compliance: A Step-by-Step Guide
The practical building blocks of a GDP-compliant warehouse: mapping, monitoring, deviations, calibration and the documentation an inspector will ask for.
Read guide →Managing Temperature Excursions: A Decision Framework
A step-by-step framework for handling a temperature excursion: detect, contain, assess impact with stability data and MKT, decide, and document.
Read guide →References & further reading
This page is general guidance, not regulatory or legal advice. Seemoto supports the requirements these frameworks enforce; achieving compliance depends on your full quality system. Confirm specific obligations with your competent authority or quality team.
Other compliance topics
Talk to us about GMP monitoring
Tell us about your environment and compliance goals. We'll map your requirements to the right monitoring setup and confirm any validation or documentation scope up front.