4/14/2019 SOP for Calibration of Instruments in Production and Quality Control : Pharmaceutical Guidelines

SOP for Calibration of Instruments in Production and Quality Control

Standard operating procedure to calibrate the production & quality control instruments and preparation of calibration plan.

1.0 OBJECTIVE
To lay down the procedure for calibration of instruments.

2.0 SCOPE
This SOP shall be applicable for calibration of critical and non-critical instruments.

3.0 RESPONSIBILITY
Officer/Executive/Assistant manager

4.0 ACCOUNTABILITY
Head of Department

5.0 PROCEDURE
5.1 Engineering department should identify with concerned departments critical / non-critical instruments.
5.2 The frequency shall depend upon the criticality of the instruments.
5.3 The type of instruments is classified in two categories. Instruments that are calibrated in-house and the instruments that are calibrated by the
external agencies.
5.4 In case of in-house calibration, head of Engineering / QA / QC / Production / Warehouse is responsible to ensure that the calibration is performed
using the certified standards traceable to national or international standards.
5.5 In case of the instruments that are to be calibrated by outside agencies, an annual calibration plan for the entire year is prepared by the
engineering department.
5.6 A monthly supplement to the original calibration plan shall be prepared to incorporate any new equipment/ instrument received and is qualified.
5.7 Based on the yearly plan, the monthly schedule for calibration of the instruments is prepared by the engineering department and is
communicated one week in advance to the outside agency as well as the concerned departments.
5.8 The calibration by outside party shall be done as per the approved procedures.
5.9 The calibration of the instruments shall be carried out on or before fifteen days after the due date.
5.10 The original calibration plan shall not be changed in case if any of the instrument is calibrated prior to the planned activities due to the major
maintenance of the equipment.
5.11 During calibration, tag the instrument/ equipment with “UNDER CALIBRATION” label duly filled by the department.
5.12 The calibration of the instruments shall cover the entire range of the instrument including the minimum, maximum and the operational range.
5.13 The calibration data shall be entered in the calibration record. The record shall contain the details of the standards used for calibration indicating
traceability, instrument serial number, validity, and the details of the instrument under calibration indicating the name of the instrument, make, ID
number, least count, accuracy and range.
5.14 The calibration data shall be verified by the concerned department personnel.
5.15 If the instrument/ equipment pass the calibration test, put label duly filled.

5.16 Symbolically update the annual calibration plan and monthly calibration schedule as indicated below,
O = Scheduled
● = Calibrated
●/ = Rescheduled & Calibrated
5.17 If the instrument/ equipment fail in calibration test, stop usages of the instrument /equipment and put “UNDER MAINTENANCE” label duly filled.
5.18 In case the critical instrument/ equipment fails in calibration, such failure shall be reported to the Head QA through the incident report and same
shall be investigated as per SOP for incident reporting and investigation.
5.19 The reason for failure and the effect of failure on the quality of the product since the last calibration shall be covered during the investigation and
a copy of the incident report shall be filed in a respective calibration file.
5.20 After investigating the reason for failure, the instrument shall be repaired/ replaced as appropriate and calibration shall be performed. If the
instrument is not repairable, make the instrument unusable and send it to scrap yard for disposal.
5.21 Executive engineering department shall fix the calibration tag on the instruments and maintain the related certificates.
5.22 For the instruments to be calibrated by an external agency, the frequency for calibration of critical instruments shall be once in six months and
for non-critical instruments once in a year.
5.23 The frequency for calibration of the pressure gauges of chilled water and hot water coil in air handling units shall be once in three years.

6.0 ABBREVIATION
6.1 SOP: Standard Operating Procedure

Survey

https://www.pharmaguideline.com/2008/01/sop-for-procedure-for-calibration-of.html 1/2
4/14/2019 SOP for Calibration of Instruments in Production and Quality Control : Pharmaceutical Guidelines
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Need Help: Ask Question

Copyright © 2008-2019 Pharmaceutical Guidelines

Setup ❘ Terms of Use ❘ FAQ

Survey

https://www.pharmaguideline.com/2008/01/sop-for-procedure-for-calibration-of.html 2/2