Calibration of Pressure Gauges, Timers & Temperature
Controller, Recorder etc. SOP
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1.0
PURPOSE:
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1.1.
To establish a method for calibration of
pressure gauges, timers, temperature controller / recorder etc installed on
different equipments in all departments.
2.1. This procedure establishes
the method to be used for calibration of pressure gauges, timers, temperature
controller / recorder etc installed on different equipments in all departments
at _________Pharmaceuticals.
3.1. Quality Assurance Manager
3.2. Maintenance Incharge.
3.3. QA Officer
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4.0 PROCEDURE:
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4.1. Pressure
gauges, timers & temperature controller / recorders are calibrated as per
plan (F-09-02). The master list (F-09-01) includes these instruments / gauges.
4.2. In-house
& calibration by external source is done/
4.3. External
Calibration arranged by QC Manager through authorized external source &
certificate of Calibration is maintained on record.
4.4. Instruments
/ Gauges performing within specified range are labeled with calibration
stickers.
4.5. Engineering/
Maintenance department coordinates with
QA Incharge to implement calibration plan and concerned department maintains
record of in-house Calibration.
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5.0
REVIEW FREQUENCY:
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SOP will be reviewed at least annually.
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EVIDENCES OF RECORDS & REFERENCES
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Calibration Master List. (F-09-01)
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FORMAL KPIs
(Key Performance Indicators)
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Maintaining the record and availability of the
record as and when required
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Pressure Gauges not calibrated on time and as
per scheduled.
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Exact Positive and Negative pressure not
maintained or identified.
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Calibrated the Pressure gauges on time and in the presence
of QA Personnel
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QA Officer/
Maintenance Incharge
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