SOP for Action to be Taken for Unusual Observation for Instrument During Calibration : Pharmaceutical Guidelines

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.


This procedure is applicable to an instrument which is calibrated in the 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 the concerned Executive regarding the out of calibration incidence of the instrument.
5.2 Q.C. Executive shall go through the problem arisen and shall try to rectify the problem if possible within available parameters and guideline received from the manufacturer.
5.3 He shall inform to maintenance department if the problem is not rectified or solved.
5.4 If the problem is arisen of other technical nature and cannot 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 analyzed 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 analyzed 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 a specified limit as per release specification.
5.10 In case it does not comply with release specification, ensure that it complies with the regulatory specification.
5.11 In case if it does not comply 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 do not comply with + 1% criteria.
5.13 Ensure that the revised results of listed RM comply 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.
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