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SOP for Calibration Procedure for Hygro-Thermometer

OBJECTIVE
To lay down a procedure for calibration of hygro-thermometer.

SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY
The IPQA staff is responsible for implementation of the process.
The QA In-Charge is responsible for the execution and compliance of the procedure.

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PROCEDURE
Measuring Range: Temperature – 100C to 500C
                                  RH – 20% to 95%.
  • Collect in house hygro-thermometer and compare it with standard hygro-thermometer.
  • Standard hygro-thermometer should be validated by external body.
  • Check the date of validity of standard hygro-thermometer.
  • Keep in-house hygro-thermometer with standard hygro-thermometer in one place.
  • Check the reading room in-house and standard hygro-thermometer at 9.00AM, 1.00PM and 5.00PM and record it in calibration log.
  • The average tolerance limit is +/-5%R.H.
  • Frequency of calibration: Once a Month.
  • Calibration details shall be entered in Annexure-1.

ABBREVIATION(s)
Q.A : Quality Assurance
SOP : Standard Operating Procedure
No. : Number

ANNEXURE(s)
Annexure No. 1 -  Calibration log for hygro-thermometer

REVISION CARD
Nil

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