Follow
Manager QC or his designee shall assign the analytical work and allot samples to trained and approved analyst.
After getting the sample allotted, the analyst shall collect analytical worksheet/s depending on the number of samples, and get the same approved by QC manager or designee.
The analyst shall also collect the current approved specification and STP from the designated place in the QC laboratory.
The analyst shall then collect the allotted sample/s from the sample room and check the label for its accuracy with the assigned sample and the worksheet he has collected.
In case of any discrepancy he shall approach Manager QC or designee for clarifications and pick the correct sample.
In case of the unlikely situation where the sample allotted is not found in the sample room, he shall inform Manager QC or designee about it, who shall investigate to identify the erroneous sample allotment.
If the sample allotted is found out, the analyst continues with the analysis. In the event of the sample allotment being erroneous, the collected worksheets shall be deposited with Manager QC or designee, who shall then proceed to cancel the same in the designated log book.
After collecting the sample and all related documentation for conducting the analysis, the analyst goes through the STP and starts to conduct the tests taking all necessary precautions as indicated therein.
The analyst shall follow all procedures and practices mentioned in the STP correctly, without making any compromises to quality of analysis and to avoid any inadvertent errors.
The analyst shall document details of all preparations, like, sample, standard, reagents, dissolution media, disintegration test media, buffers, mobile phase and diluent, in the analytical worksheet.
If the analytical work sheet does not give the provision for recording the complete preparation of the preparations cited above, then the analyst shall record the preparation in the format provided in Annexure.
While selecting any equipment for analysis, the analyst must review the calibration status before proceeding for the analysis.
The analyst shall fill in the equipment status label before starting the analysis and place it in the holder kept beside/ over the equipment. The template of the status label is given in Annexure.
All preparations including dilutions must be retained till results of the analysis is calculated, regardless of the solution stability.
The analyst shall always use fresh vials for HPLC and GC analysis. Used vials must be disposed off after the results are calculated.
In case of chromatographic and spectrophotometric analysis, the analyst shall check the system suitability requirements as indicated in the STP, before proceeding for the analysis. Refer SOP on System Suitability Test for Chromatographic & Spectrophotometric Analysis, for more details.
If the analyst needs to make alterations to the ratio of the mobile phase within the specified limits of the STP, record the same in the log register Annexure II along with the appropriate reason.
While conducting analysis on HPLC / GC, analyst shall take print out of sample set, instrument method, processing method and method set. In addition the analyst shall also print the injection set post data acquisition and attached all these to the processed chromatograms.
The analyst shall clean equipments like Dissolution apparatus, Disintegration apparatus after use and store the cleaned paddles or baskets in designated place.
The analyst shall, at the earliest possible opportunity after completion of the chromatographic acquisition, process and print all generated chromatograms, and complete the calculation of results.
If for some reason, the analyst re processes the chromatograms, either by mistake or for a correction, all processed chromatograms must be printed and attached to the analytical worksheet of that batch. The reason for the reprocessing must be explicitly made on the chromatogram and signed and approved by reviewer.
The analyst shall use the pre validated excel sheets, to calculate results. Once the results confirm to the specifications then the retained solutions may be discarded and glassware given for washing.
If on calculations, an out of specification (OOS) or an out of trend (OOT situation is observed, the analyst shall participate in the laboratory investigation, conducted as per relevant SOPs, by manager QC or designee to identify the root cause of the error.
If any of the test needs to be repeated because of unforeseen incidents / OOS/ OOT OOE, the analyst shall make relevant entries in the re-test log book.
