STANDARD OPERATING PROCEDURE CALIBRATION OF EQUIPMENT

STANDARD OPERATING PROCEDURE

SUBJECT :                     CALIBRATION OF EQUIPMENT

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To lay down a procedure with respect to frequency of calibration of various Equipment and Maintenance of Records thereof.

2.0       POLICY:

Periodically calibrated Equipment will be used for maintaining accuracy in analytical / dispensing / manufacturing process.

3.0       PROCEDURE:

3.1       The equipment required to be calibrated is first listed and establish the calibration procedure & frequency of calibration is established.

3.2       Calibration procedures are prepared for individual equipment from the pharmacopoeias or instruction manuals of equipments/in-house specifications.

3.3       Calibrate different equipments according to their calibration procedure and frequency to ascertain whether the performance of the equipment is satisfactory and accurate.

3.4       All the working standards used for calibration purpose are stored in a separate rack.

3.5       Results obtained from instrument calibration is checked against standard results and records are maintained.             

3.6       Instruments like H.P.L.C, UV-Visible spectrophotometer, Melting point apparatus, Polarimeter, Vacuum Oven are calibrated once in every three months.

3.7       Analytical Balances, pH meter are crosschecked daily before use.

3.8       Balances used in Production and Dispensing area are crosschecked every day against standard weights given by Govt. authorities and calibrated once in three months by Q.A dept. and once a year by outside agency.

                                   

 3.9      Calibrated equipment should have a Calibration tag with the following details;

Name of equipment                                         Calibration due

Calibrated on                                                   Calibrated by

Remarks                                 

When any equipment if found Out of Calibration, report to the Service Engineer for rectification. The equipment is to be Re-calibrated after servicing is done. The calibration certificates received from external agencies should be reviewed by Q.A and attested.

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY: Executive (Q.A).

1.0              REVIEW GUIDE:  Calibration records.

7.0       ANNEXURE: 1. Calibration of equipment.

2. Standard Weights, Filling Machines Nozzles and Weighing Scales: - External Calibration.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x