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

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

ANNEXURE

Annexure No. 1 - Calibration log for hygro-thermometer

REVISION HISTORY

Nil

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