Standard Operating Procedure For Calibration Of Equipments And Its Validation

by Pharmadocx Consultants

PURPOSE:  To implement a method of calibration and validation of equipments already in operation.

RESPONSIBILITY  : 1) Production In-charge                       

                                          2) Q.A. In-charge


All measurement gauges and instruments are calibrated periodically as per an established schedule:

1)         Weighing Machines                            -Daily

2)         Pressure/Temperature Gauges -Once in three months

3)         Control Instruments like capacitors,   -Once in six months

            Solenoid Valves with gauges, Flow  Meters, etc.

Great care is taken that the calibration is undertaken scientifically and the weights used are of standard measure approved by weights & measurement department.

Methods of calibration for equipment and records indicating dates are kept in a file with the Q.A. Department.  Dates of last calibration and due date for next calibration, name of person performing calibration, are recorded for each piece of testing and measuring equipment.

Control of Measuring and Test Equipment:

Adequate tests of measuring equipment are maintained and calibrated as per established schedule. The Quality Control Department keeps methods of calibration for equipment and records indicating dates of calibration performed in a file.

Dates of last calibration and due date for next calibration and name of the person performing calibration are recorded for each piece of measuring equipment.

Balances and scales are calibrated according to schedule.

The respective calibration methods used for the various instruments is as follows:

1. pH Meter: Daily once according to Standard practice

2. Analytical balances: Twice in a week according to Standard practice.

Procedure for Calibration:

a) Gauge / Instrument under calibration is kept on a leveled place (table top).

  • Standard measure is brought from ISI. CDL or International Standard likes SIGMA, etc.
  • Fist the zero is set.
  • Measurement / Parameter is measured for due standard.
  • If the reading is equal with the standard no adjustment knob is set right and further reading is taken with the knob/Slit open.
  • If the reading is not the same, further adjustment is done and continued till such time the standard reading is obtained.
  • For weights/measures, standard weights available from weight and Measure department are used for calibration of the weighing machines.
  • For validation the same procedure is followed before expiry of validity period.
(GM Production)
Checked by:
(QA Manager)
Authorised by:
(Director Technical)

(Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

11 June 2023

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