SOP for Calibration Procedure for Hygro-Thermometer

OBJECTIVE

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

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The IPQA staff is responsible for the 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 – 10℃ to 50℃

                                  RH – 20% to 95%.

• Collect in-house hygro-thermometer and compare it with standard hygro-thermometer.
• Standard hygro-thermometer should be validated by the external body.
• Check the date of validity of the 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 the 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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