Calibration of Pressure Gauges, Timers & Temperature Controller, Recorder etc. SOP

Calibration of Pressure Gauges, Timers & Temperature Controller, Recorder etc. SOP

1.0   PURPOSE:

1.1.             To establish a method for calibration of pressure gauges, timers, temperature controller / recorder etc installed on different equipments in all departments.

2.0    SCOPE:

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.

3.0   RESPONSIBILITY:

3.1.      Quality Assurance Manager

3.2.      Maintenance Incharge.

3.3.      QA Officer

4.0    PROCEDURE:

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.

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.

6.0      RISK ANALYSIS:

EVIDENCES OF RECORDS & REFERENCES			Calibration Master List. (F-09-01)
FORMAL KPIs (Key Performance Indicators)			Maintaining the record and availability of the record as and when required
GENERAL RISKS			CONTROL MEASURES		CUSTODIAN
Risks	Impact
Pressure Gauges not calibrated on time and as per scheduled.	Exact Positive and Negative pressure not maintained or identified.	Calibrated the Pressure gauges on time and in the presence of QA Personnel		QA Officer/ Maintenance Incharge