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Procedure for calibration of Instruments/ Equipments.Quality Assurance

  • 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

     

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