GMP and temperature monitoring
Good Manufacturing Practice requires the conditions that affect product quality to be under control and documented. Here is what that means for your measuring points.
What does GMP require of temperature monitoring?
GMP rarely mentions monitoring equipment directly. The rules say that manufacturing conditions must be under control, that deviations must be detected and handled, and that all of it must be documented. Temperature, humidity, CO2 and differential pressure are among the conditions that typically fall under this.
In practice this means continuous measurement instead of spot checks, alarms that get through outside working hours too, a log that cannot be altered, and sensors with traceable calibration, so the measurement has a known uncertainty.
Which points must be monitored, and how tightly, is decided by your own risk assessment. Two companies with the same equipment can reach different answers, and both can be right.
We deliver the system, the documentation and the validation. You set the risk assessment and the scope.
What GMP requires in practice
Continuous measurement
Not spot checks. Conditions must be documented at all times, including at night and at weekends.
Handling of deviations
An alarm must go off, someone must react, and the reaction must be documented afterwards.
Unaltered data
A log that can be edited is not documentation. The audit trail must show who did what and when.
Known measurement uncertainty
The sensors must be calibrated with a traceable certificate, otherwise you do not know how accurate the measurement is.
Documented placement
Why the sensor sits where it does. A mapping study turns the answer into data instead of an estimate.
Validated system
The system must be documented to do what it is supposed to do. We carry out that validation, alone or together with your QA.
What we deliver, and what you are responsible for
We deliver the system, the documentation and the validation: audit trail, traceable calibration certificates, timestamped readings and reports, and IQ, OQ and PQ carried out by us, alone or in close cooperation with your QA. You set the risk assessment and the validation scope.
From requirement to documentation
What GMP asks for is already in the system. The question is how you get it out.
Measurement
The sensors measure continuously, and the data logger stores locally for up to 28 days, so a network outage does not leave a gap in the documentation.
Deviation
Limits with delay distinguish normal use from real loss. OCEAlert gives calls, SMS or email and escalates until someone acknowledges.
Recording
Readings, alarms, acknowledgements and user actions are stored in an audit trail that cannot be altered.
Presentation
Choose a period and export the report. The calibration certificate is retrieved on each individual sensor.
Frequently asked questions
Does GMP say we must have a monitoring system?
No. It says that conditions must be under control and documented. A system is the practical way to meet that, not a requirement in itself.
How many measuring points does GMP require?
It is not fixed. The number follows from your risk assessment and from the size and zones of the room. A mapping study provides the basis.
Should we map before setting up fixed sensors?
It is strongly recommended, and at an inspection it is often what you are asked about. Without the study, the placement is an estimate.
Who carries out the validation?
We do, alone or together with your QA. You set the scope, and we carry out the validation and deliver the documentation.
What is the difference between GMP and GDP?
GMP covers manufacturing, GDP covers storage and distribution. Many companies are covered by both.
What about Annex 11?
Annex 11 is the part of EU GMP that deals with computerised systems. So it applies to the software itself and is described on its own page.
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