Procedure for calibration of Instruments/ Equipments.Quality Assurance

December 8, 2016August 28, 2020 Pharma Editor

OBJECTIVE :
To lay down policy for calibration of Instruments/Equipments.
RESPONSIBILITY :
Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any.
Heads of the concerned department to ensure compliance.
Procedure :
All the instruments associated with the processing and testing of materials and products shall be calibrated.
There shall be an SOP for calibration of each Instrument/Equipment which needs periodic in-house calibration.
Calibration SOP of respective Instrument/Equipment shall mention the calibration schedule and acceptance criteria.
Calibration shall be done using certified calibration standards traceable to National/NIST standards either in-house or from a certified outside agency.
An annual calibration schedule shall be prepared by individual departments for equipment’s required to be calibrated by the department personnel or outside agency.
The calibration data shall be entered in the calibration record. The calibration record shall contain details of calibration standards like Name, Control No., Calibrated on, Next calibration due on etc. The calibration data shall be verified by second person.
Calibration shall be carried out on the same day on which Instrument / Equipment’s due for calibration. If due date falls on holidays / weekly off’s calibration shall be performed before the due date.
During calibration, tag the Instrument/Equipment with “Under Calibration” label duly filled .
Any Instrument/Equipment “Under Calibration” shall not be used.
If the Instrument/Equipment passes the calibration test, put “Calibrated” label duly filled .
If the Instrument/Equipment fails in calibration test, put “Calibration Failed” label duly filled .
In case the Instrument/Equipment fails the calibration, failure shall be investigated by concerned personnel through incident report as per guidelines “Deviation and
Incidents”. The reason for failure and the effect of failure on quality of product since last calibration shall be covered during investigation. A copy of incident report shall be filed in the respective calibration file.
In case a calibration is performed due to a breakdown, repair, change of parts or any other reason, before the next scheduled date of calibration, the same shall be recorded in the respective calibration record.
The scheduled date of calibration shall not be disturbed due to any calibration performed before the scheduled date of calibration.
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History

Date Revision Number Reason for Revision

– 00 New SOP

Date	Revision Number	Reason for Revision
–	00	New SOP

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