SOP for Calibration Programme

OBJECTIVE

To lay down the procedure for defining the calibration program of Quality Control Instruments as per specified frequency

SCOPE

This SOP shall apply to all the instruments, installed in the Quality Control Department at XYZ Limited.

RESPONSIBILITY

Execution: Chemist – QC department.

Checking: Chemist and Above – QC department.

PROCEDURE

• Calibration of QC instruments falls in two categories.

1. Internal calibration: Such calibration is carried out by using standards available in the laboratory.
2. External calibration: Such calibration is carried out by third-party

• The annual schedule shall be prepared at every last month of the previous year or can be revised as per the requirement.

• Calibration to be carried out as per frequencies.

ALSO READ: SOP for Calibration of AUW 220 Analytical Balance

• Before starting calibration, check the availability and validity of the required standards.
• Ensure that all standard chemicals meet the requirements of the respective pharmacopeia and use only qualified instruments (if required) for calibration.
• Before starting calibration go through the respective procedure and protocol. In case of any discrepancy, contact the Manager.
• Perform the calibration/performance/operational check as per specified procedure
• After completion of the respective check, write down the status of the instrument on the calibration card and sign it.
• In case of results that are not found satisfactory, immediately inform the Asst. Manager & above of the QC Department.
• Write down all observations/ results in the respective protocol and the approval of the authorized person.

• Before approval of the records, an authorized person will check all the calculations and ensure that the calibration is carried out as per standard procedure and results are satisfactory within specified limits.
• Make entries in the calibration schedule; refer Annexure-1
• If calibration of an instrument is not found satisfactory and an error is not identified, label the instrument as ‘Out of calibration’.

REFERENCE

Nil.

ABBREVIATION

SOP: Standard Operating Procedure

QC: Quality Control

ANNEXURE

Annexure No. – 1 - Specimen format for annual calibration schedule

REVISION HISTORY

Nil

ALSO READ: SOP for Document Control, Issuance and Numbering System