Standard Operating Procedure (SOP) and Guideline for Handling of Out of Calibration (OOC) results of Laboratory Instruments and Equipment like HPLC system, UV Spectrophotometers, Polarimeters etc.
Handling Out of Calibration (OOC) Results
1.0 OBJECTIVE :
- To lay down a procedure for the handling out of calibration (OOC) results of Laboratory Instruments and Equipment.
2.0 SCOPE :
- This SOP is applicable to all the Laboratory Instruments and Equipment at Pharmaceutical drug manufacturing plants.
3.0 RESPONSIBILITY :
- Executive-QC, Head-Quality Control, Head- Engineering, Head-Quality Assurance
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DEFINITION(S)
- Calibration – the act of checking or adjusting (by comparison with a standard) the accuracy of a measuring instrument; “the thermometer needed calibration”
4.0 PROCEDURE – Handling Out of Calibration (OOC) Results :
- Perform calibration of instrument or measuring device as per the procedure given in respective SOP of the instrument.
- During calibration if the results are found to be out of calibration (OOC), then immediately stop using the same and label it as “OUT OF CALIBRATION”.
- Immediately inform to supervisor for the further action.
- The supervisor shall raise an out of calibration (OOC) Evaluation form (Annexure-I)
- The calibration team including the Head of the Department and Head Quality Assurance or their designee shall review the following:
- Degree of out of calibration (OOC) and criticality of the result (impact on product).
- Any supporting data like system suitability, system performance or back up data.
- Impact analysis for the product or process that was analyzed/measured during the period between the last calibration and the current calibration.
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The Head-QA shall design the action plan based on the review and make report that includes:
- The calibration findings, instrument used for the calibration and its calibration status, instrument traceability.
- The degree of failure (the level of out of calibration (OOC) from standard).
- The degree of failure shall be decisive for finalization of further the action plan.
- The impact of failure on products, which were analyzed, and or process, which were measured.
- This can be done by reviewing but not limited to sequential log, instrument equipment / usage log.
- Analysis of control sample or in-process sample (if the process is on going) for the specific tests using the instrument or device.
- In case other supporting data are available which can justify the impact, it may not be necessary to analyze the entire impacted product.
- This needs to clearly mentioned in the action plan and justified.
- The Head-QA shall implement the action plan.
- After completion of implementation of plan, the team shall review the data and appropriate action shall be decided for the affected product.
- This may be but not limited to the product recall, information to customer, etc.
- Out of calibration (OOC) incidence shall be closed out by Head QA after thorough review of action plan, execution, data review, and action based on the findings.
- The section Head shall initiate a parallel activity to rectify the instrument/measuring device and recalibration shall be performed before putting in actual practices.
- Record the out of calibration (OOC) evaluation as per Annexure-I.
5.0 ANNEXURE- Out of Calibration (OOC) :
Annexure-I: Out of calibration (OOC) Evaluation Form.
- Out of Calibration Instrument / Device Details :
| Name: |
Identity No.: |
Dept.: |
| Date of previous calibration: |
Previous calibration status: |
| Date of current calibration: |
Calibration status: |
| Attached to equipment / System (give details): |
| Reported By (Sign / Date): |
HOD (Sign/ Date) : |
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- Impact Analysis of Out of Calibration (OOC) results
- Investigation Team (decided by Head, QA) Sign/ Date:
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| Name |
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| Date |
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| Calibration Findings |
| Degree of failure (mention if the product/ process has been is directly impacted) |
| Impact analysis: (attach a separate sheet if necessary): |
| On product (e.g list no. of batches impacts, parameters impacted, etc) |
On process (parameters compromised, system impacted) |
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| Product Name |
Batch No. |
Test applied |
Results |
Remarks |
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| Others if any: |
- Review of Corrective / Preventive Action plan
- Closing of Out of calibration (OOC) (Attach all supporting data, if any)
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| Checked By |
Approved and Closed By |
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Department Head |
Head- Utility |
Head – QA |
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| Date |
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