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SOP on Calibration Management in Pharmaceutical Industry



  1. Objective:

To lay down a procedure for management of calibration procedure.

  1. Scope:

This procedure is applicable for QC instruments, production equipment, utility service and all other equipment used for measurement.

  1. Responsibility:

Quality control, Production, Warehouse, Engineering and Quality Assurance

  1. Procedure:

4.1 Head of concerned department along with QA and engineering department shall       identify equipment/ instrument to be calibrated.

4.2 Prepare calibration planner for all equipment/instrument. Equipment planner shall   contain information like equipment name, equipment ID, location, calibration date    next calibration due date and signatures.

4.3 Newly purchased equipment shall be calibrated and shall be incorporated in       calibration planner.

4.4 Calibration shall be carried out in- house or by contracted external agencies.

4.5 Classify the equipment/instrument as critical and non-critical based on usage and criticality.

Critical equipment/instrument: Which directly measures or used for critical test       parameters or critical process parameters. Its failure my lead to stoppage of process.

Non- critical equipment/instrument: Which is used for less critical activity and     failure of which may not have impact on process or quality attributes of product.

4.6 Calibration period of critical equipment/instrument shall not be more than 6 months   and for non-critical equipment shall not be more than 12 months until frequency       defined in pharmacopoeia or GMP/regulatory guidelines.     

4.7 Responsibility of calibration:

4.7.1 Designated person in QC shall be responsible for calibration of QC instrument.

4.7.2 Production department shall be responsible for calibration of IPQC instrument.

4.7.3 Engineering department shall be responsible for calibration of production          equipment, sensors, measuring devices and utilities.

4.7.4 Primary user department shall be responsible for calibration of balances installed    in different department like warehouse, production, QC etc.

4.7.5 Stamping of floor balances shall be responsibility of engineering department.

4.8 In- house calibration shall be performed as per internal SOP and external       calibration can be accepted as per external agency’s SOP approved by QA, QC and       engineering department.

4.9 Acceptance criteria of calibration

The acceptance criteria shall be based upon:

– Acceptance criteria mentioned in pharmacopoeia or in GMP/regulatory guidelines.

– Recommendation from equipment/instrument manufacturer.

– Based on usage of equipment/instrument.

– Limit established in national standard.

4.10 List of acceptance criteria of calibration for all equipment/instrument shall be prepared and shall be maintained.

4.11 Management of calibration activity:

4.11.1 Calibration due date and frequency shall be identified by calibration planner by user department and accordingly calibration activity shall be planned.

4.11.2 The standards used for calibration activity should have traceability of calibration   to national or international standards.

4.11.3 All the calibration records procured from external agency shall be reviewed by      designated person. If calibration record found satisfactory then accept the            calibration certificate from external agency.

4.11.4 Calibration status label from external agency can be affixed on equipment/instrument which have been calibrated by them.

4.11.5 Affix in-house calibration label on equipment/instrument which have been            calibrated in- house.

4.11.6 Calibration shall be completed within + 7 days from the due date for critical            equipment/instrument and for non critical equipment shall be completed within +          15 days. Deviation shall be initiated if calibration is not performed within the           stipulated time and decision for usage shall be based on impact assessment.

4.12 Recalibration

4.12.1 The activities of recalibration shall be planned in such a way that it should be         completed within due date.

4.12.2 Affix under calibration label on equipment/instrument if calibration is planned and on-going.

4.13 Both in-house and external agency calibration certificate/document should contain at least below information:

– Equipment/Instrument name and ID

– Location

– Minimum and maximum operating range with least count

– Test carried out with observed reading and acceptance limit

– List of master equipment used

– Date of calibration and next calibration due date

– Conclusion

– Name, signature of the person who performed calibration with date

– Name and signature of authorised person with date

4.14 Management of out of calibration:

4.14.1 Any out of calibration situation shall be brought into notice of department head.

4.14.2 Head of department shall review the calibration and shall confirm that the            equipment/instrument is out of calibration. Affix the out of calibration label            to prevent further use.

4.14.3 Head of department shall notify QA department.

4.14.4 Deviation shall be initiated by user department and impact assessment shall be       performed on released batches.

4.14.5 Servicing of equipment shall be arranged as early as possible.

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