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Two free downloads and the terms you will meet.
Glossary
The words, in one line.
- URSUser requirement specification
- What the room or unit must do, written before design.
- DQDesign qualification
- Checks the design meets the URS.
- IQInstallation qualification
- Checks it is installed as specified.
- OQOperational qualification
- Checks it works within limits across its range, usually empty.
- PQPerformance qualification
- Checks it performs under real conditions, usually loaded.
- Temperature mapping
- A study that finds the warmest and coldest points of a space under defined conditions.
- Hot spot · cold spot
- The warmest and coldest positions found by mapping. Monitoring probes go there.
- Continuous mapping
- Enough sensors stay in place to keep proving the whole space is in range.
- Calibration
- Comparing an instrument with a reference traceable to national standards.
- MKTMean kinetic temperature
- A single temperature that reflects the thermal stress of a fluctuating profile.
- RPResponsible Person
- Named person accountable for GDP at a wholesale distributor.
- QPQualified Person
- Named person who certifies batches under EU GMP.
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