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.


      To lay down procedure for calibration of instruments.

2.0 SCOPE:

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


      Officer/Executive/Assistant manager


      Head of Department


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 out side agencies, an annual calibration plan for the entire year is prepared by 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, monthly schedule for calibration of the instruments is prepared by 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 of 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 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 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 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 product since last calibration shall be covered during investigation and a copy of 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 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 a three years.


6.1 SOP : Standard Operating Procedure

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.
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