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SOP for Action to be Taken for Unusual Observation for Instrument During Calibration

Standard operating procedure for problem found in any instrument during Calibration.


       To lay down the procedure for action to be taken during unusual observation for instrument during calibration.

2.0  SCOPE

       This procedure is applicable to instrument which are calibrated in quality control department.


3.1  Doing      : Technical Assistant
3.2  Checking : Executive/Manager


       Head of the Department


5.1  Q.C. Assistant calibrating the instrument shall inform to the concerned Executive regarding the out of calibration incidence of the instrument.
5.2  Q.C. Executive shall go through the problem arised and shall try to rectify the problem if possible within available parameters and guideline received from manufacturer.
5.3  He shall inform to maintenance department if the problem is not rectified or solved.
5.4  If the problem is arised of other technical nature and can not be rectified, he shall inform with the details of the problem to the authorized service center or manufacturer regarding the nature of the problem and intimate them to send the service engineer to rectify the problem at the earliest.
5.5  After servicing the instrument by service engineer re-calibrate the instrument as per respective SOP’s and keep the record of the same. Note down the details in respective instrument history card.
5.6  Analyse the product/batch which was last analysed on that particular instrument to confirm the result.
5.7  The difference between the initial result & the new result after re-calibration should not differ by more than 1%.
5.8  If the result of the last analysed batch/product is not within this + 1% of initial result then select second last batch/product for analysis and continued doing testing of the batches/product in reverse order till the results are found within the + 1% of the initial result.
5.9  List out the batches not complying the + 1% criteria and ensure that the revised results comply with specified limit as per release specification.
5.10  In case if does not comply with release specification, ensure that it complies with regulatory specification.
5.11  In case if it is not complies with regulatory specification then inform to manager QC for further action.
5.12  In case of raw material/list out the RM if the revised results not comply with + 1% criteria.
5.13  Ensure that the revised results of listed RM are complies with laid down specifications.
5.14  In case if it is found not complies, immediately instruct RM store to stop the further use through proper channel and inform to QC Incharge for further action.
5.15  List out the batches manufactured using the particular RM.
5.16  Follow step 5.9 to 5.12 for the listed out batches.

Related: Handling of Out of Calibration Instruments and Equipment


6.1  Q.C.= Quality control
6.2  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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

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